AMIKACIN ( DrugBank: Amikacin )


2 diseases
IDDisease name (Link within this page)Number of trials
60Aplastic anemia1
299Cystic fibrosis51

60. Aplastic anemia


Clinical trials : 245 Drugs : 318 - (DrugBank : 86) / Drug target genes : 44 - Drug target pathways : 166
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-005152-34-ES
(EUCTR)
26/03/201222/11/2011Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia).Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropenia In-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis.
MedDRA version: 14.0;Level: PT;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0;Level: LLT;Classification code 10066156;Term: Empiric treatment;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
INN or Proposed INN: ACICLOVIR
Other descriptive name: ACICLOVIR
INN or Proposed INN: AMIKACIN
Other descriptive name: AMIKACIN
INN or Proposed INN: AMPHOTERICINE B, LIPOSOME
Other descriptive name: AMPHOTERICINE B, LIPOSOME
INN or Proposed INN: CASPOFUNGIN ACETATE
Other descriptive name: CASPOFUNGIN ACETATE
INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: CIPROFLOXACIN
Other descriptive name: CIPROFLOXACIN
INN or Proposed INN: TRIMETHOPRIM SULFATE
Other descriptive name: TRIMETHOPRIM SULFATE
INN or Proposed INN: SULFAMETH
José Miguel Cisneros HerrerosNULLNot RecruitingFemale: yes
Male: yes
Phase 3Spain

299. Cystic fibrosis


Clinical trials : 1,695 Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02535130
(ClinicalTrials.gov)
August 201524/8/2015Evaluation of Nebulization and Positive Expiratory Pressure CombinationCystic Fibrosis;Healthy SubjectsDevice: Positive expiratory pressure;Drug: amikacine nebulizationCliniques universitaires Saint-Luc- Université Catholique de LouvainNULLRecruiting16 Years55 YearsBoth15N/ABelgium
2NCT02489955
(ClinicalTrials.gov)
February 201518/5/2015Antibiotic Nephrotoxicity in Adult Patients With Cystic FibrosisProspective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: Amikacin;Drug: Tobramycin;Drug: ColomycinThe Leeds Teaching Hospitals NHS TrustNULLRecruiting18 YearsN/ABothN/AUnited Kingdom
3ChiCTR-IPC-15005915
2015-01-312014-07-06A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of BronchiectasisA Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis non-cystic fibrosis bronchiectasisExperimental group:Routine treatment combining with the therapy of bronchoalveolar lavage and local drug injection (Amikacin);Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of MedicineNULLRecruiting1880BothExperimental group:50;NULL
4NCT02081963
(ClinicalTrials.gov)
March 20146/3/2014Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis BronchiectasisA Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis BronchiectasisNon-Cystic Fibrosis BronchiectasisDrug: Amikacin;Drug: Normal salineQilu Hospital of Shandong UniversityNULLCompleted18 Years80 YearsAll178Phase 4China
5NCT02084043
(ClinicalTrials.gov)
March 20148/3/2014In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive VentilationIn Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;AsthmaDrug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)University Hospital St Luc, BrusselsUniversité Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, SwitzerlandCompletedN/AN/ABoth3N/ABelgium;Switzerland
6EUCTR2011-000443-24-NL
(EUCTR)
25/04/201306/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
7EUCTR2011-000443-24-DK
(EUCTR)
14/12/201222/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
8NCT01316276
(ClinicalTrials.gov)
October 5, 201214/3/2011Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) InfectionLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaCystic FibrosisDrug: Liposomal amikacin for inhalationInsmed IncorporatedNULLCompleted6 YearsN/AAll206Phase 3Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;United Kingdom
9EUCTR2011-000441-20-NL
(EUCTR)
11/09/201206/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom
10NCT02201082
(ClinicalTrials.gov)
September 201220/2/2014Evaluation of the Timing of the Nebulization Related to the Physiotherapy SessionCystic FibrosisProcedure: Airway clearance technique;Drug: Amikacin nebulizationCliniques universitaires Saint-Luc- Université Catholique de LouvainNULLCompleted16 Years50 YearsBoth15N/ABelgium
11EUCTR2011-000441-20-BG
(EUCTR)
13/06/201203/05/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
12EUCTR2011-000443-24-SE
(EUCTR)
24/05/201207/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
13EUCTR2011-000441-20-IE
(EUCTR)
02/05/201226/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Code: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
14EUCTR2011-000443-24-IT
(EUCTR)
10/04/201219/03/2012Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
250Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
15EUCTR2011-000441-20-DK
(EUCTR)
29/03/201222/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
16NCT01315691
(ClinicalTrials.gov)
February 29, 201214/3/2011Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas AeruginosaRandomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaCystic FibrosisDrug: Liposomal amikacin for inhalation;Drug: Placebo for liposomal amikacin for inhalationInsmed IncorporatedNULLWithdrawn6 YearsN/AAll0Phase 3NULL
17NCT01315678
(ClinicalTrials.gov)
February 29, 201214/3/2011Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa InfectionsRandomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaPseudomonas Aeruginosa InfectionDrug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.;Drug: Tobramycin inhalation solution using a PARI LC® Plus nebulizer.Insmed IncorporatedNULLCompleted6 YearsN/AAll302Phase 3Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;Sweden;United Kingdom
18EUCTR2011-000443-24-BE
(EUCTR)
30/01/201225/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
19EUCTR2011-000441-20-BE
(EUCTR)
30/01/201225/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
Product Code: N/A
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany
20EUCTR2011-000443-24-PL
(EUCTR)
20/01/201206/10/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
21EUCTR2011-000443-24-DE
(EUCTR)
11/10/201130/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
22EUCTR2011-000442-38-BG
(EUCTR)
03/10/201105/07/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
23EUCTR2011-000443-24-BG
(EUCTR)
03/10/201128/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
24EUCTR2011-000441-20-IT
(EUCTR)
01/10/201108/03/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: Tobi
INN or Proposed INN: TOBRAMYCIN
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy
25EUCTR2011-000443-24-ES
(EUCTR)
22/09/201103/11/2011Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta Arikace en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosaEstudio de seguridad y tolerabilidad a largo plazo de la administración abierta de amicacina liposomal para inhalación (Arikace) en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa - NCT0131627 Infeccion pulmonar por Pseudomonas Aeruginosa/ colonizacion en pacientes con fibrosis quistica
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace TM)
INN or Proposed INN: Sulfato de amikacina
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
26EUCTR2011-000442-38-ES
(EUCTR)
21/09/201111/11/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden
27EUCTR2011-000441-20-ES
(EUCTR)
21/09/201111/11/2011ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSAESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108 Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Amikacina liposomal (Arikace?)
INN or Proposed INN: Sulfato de amikacina
Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador
INN or Proposed INN: tobramicina
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands
28EUCTR2011-000441-20-DE
(EUCTR)
19/09/201130/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
29EUCTR2011-000443-24-GR
(EUCTR)
09/08/201123/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
30EUCTR2011-000443-24-IE
(EUCTR)
05/08/201126/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
31EUCTR2011-000441-20-GB
(EUCTR)
03/08/201124/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
32EUCTR2011-000443-24-GB
(EUCTR)
03/08/201124/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
33EUCTR2011-000443-24-FR
(EUCTR)
28/07/201131/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
34EUCTR2011-000443-24-AT
(EUCTR)
22/07/201127/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
35EUCTR2011-000441-20-AT
(EUCTR)
19/07/201121/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
36EUCTR2011-000441-20-GR
(EUCTR)
15/07/201122/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
37EUCTR2011-000443-24-SK
(EUCTR)
04/07/201120/02/2014Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands
38EUCTR2011-000441-20-SK
(EUCTR)
04/07/201125/11/2014Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
39EUCTR2011-000443-24-HU
(EUCTR)
29/06/201111/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
40EUCTR2011-000441-20-HU
(EUCTR)
29/06/201120/04/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
41NCT03905642
(ClinicalTrials.gov)
January 8, 20092/4/2019Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension PhaseMultidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) in Cystic Fibrosis Patients With Chronic Infections Due to Pseudomonas AeruginosaCystic FibrosisDrug: Arikayce™Insmed IncorporatedNULLCompleted6 YearsN/AAll49Phase 2Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Macedonia, The Former Yugoslav Republic of
42NCT00558844
(ClinicalTrials.gov)
January 200813/11/2007Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas AeruginosaPhase 1b/2a Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikayce™) in Cystic Fibrosis Patient With Chronic Infections Due to Pseudomonas Aeruginosa.Cystic FibrosisDrug: Arikayce™ 560 mg;Drug: Placebo for 560 mg;Drug: Arikayce™ 70 mg;Drug: Arikayce™ 140 mg;Drug: Placebo for 70 mg / 140 mgInsmed IncorporatedNULLCompleted6 YearsN/AAll41Phase 1/Phase 2United States
43EUCTR2006-006980-22-BE
(EUCTR)
27/06/200719/07/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin sulfate
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Hungary;Belgium
44EUCTR2006-006980-22-HU
(EUCTR)
14/06/200703/04/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Hungary;Belgium
45EUCTR2006-006980-22-SK
(EUCTR)
17/05/200723/04/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)Transave, Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Slovakia;Poland;Belgium
46NCT00777296
(ClinicalTrials.gov)
February 22, 200715/10/2008Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)Phase 2a Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) In Cystic Fibrosis Patients With Chronic Infections Due To Pseudomonas Aeruginosa.Cystic FibrosisDrug: ARIKACE™;Drug: PlaceboInsmed IncorporatedNULLCompleted6 YearsN/AAll66Phase 1/Phase 2Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Bulgaria;Macedonia, The Former Yugoslav Republic of
47EUCTR2005-004389-17-HU
(EUCTR)
28/12/200524/10/2005SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSASAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA Cystic Fibrosis with mild to moderate obstructive lung disease and chronic infection with Pseudomonas aeruginosaProduct Name: SLIT Amikacin
Product Code: TR02
INN or Proposed INN: amikacin
Other descriptive name: amikin, amiklin, amicacin, BB-K8, Biklin, Fabianol, Kaminax, Mikavir, Novamin, Pierami
Transave, IncNULLNot RecruitingFemale: yes
Male: yes
15Phase 2Hungary
48EUCTR2005-004899-21-BE
(EUCTR)
22/12/200512/01/2006Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NASafety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA Cystic FibrosisProduct Name: SLIT(TM) Amikacin
Product Code: TR02
INN or Proposed INN: Amikacin
Other descriptive name: amikin®, amiklin, amicacin, BB-K8, Biklin®, Fabianol®, Kaminax, Mikavir, Novamin®, Pierami
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
15Belgium
49NCT00153634
(ClinicalTrials.gov)
March 20048/9/2005Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)Standard vs. Biofilm Susceptibility Testing in CFCystic Fibrosis;Chronic BronchitisDrug: IV amikacin;Drug: PO azithromycin;Drug: IV ceftazidime;Drug: PO ciprofloxacin;Drug: IV meropenem;Drug: IV piperacillin-tazobactam;Drug: IV ticarcillin-clavulanate;Drug: IV tobramycinSeattle Children's HospitalCystic Fibrosis Foundation TherapeuticsCompleted14 YearsN/ABoth75N/AUnited States
50EUCTR2011-000442-38-PL
(EUCTR)
01/08/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
51EUCTR2006-006980-22-PL
(EUCTR)
22/08/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Slovakia;Belgium;Poland