CIALIS ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症1
86肺動脈性肺高血圧症33

51. 全身性強皮症


臨床試験数 : 523 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00707187
(ClinicalTrials.gov)
July 200125/6/2008Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual DysfunctionRandomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic SclerosisSystemic SclerosisDrug: CialisUniversity of Medicine and Dentistry of New JerseyNULLCompleted18 YearsN/AFemale120Phase 2United States

86. 肺動脈性肺高血圧症


臨床試験数 : 1,181 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-002354-23-NL
(EUCTR)
18/10/201331/05/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Brazil;Belgium;Poland;Romania;Netherlands;Germany;Japan
2EUCTR2012-002354-23-FR
(EUCTR)
23/08/201324/09/2015A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
3EUCTR2012-002354-23-BE
(EUCTR)
19/08/201325/02/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
35Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Netherlands;Japan
4EUCTR2012-002354-23-RO
(EUCTR)
17/07/201323/07/2014A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
134United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
5EUCTR2012-002354-23-DE
(EUCTR)
18/06/201312/02/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
35Phase 3Spain;Turkey;Austria;Israel;United Kingdom;Italy;France;Brazil;Belgium;Poland;Romania;Germany;Netherlands;Japan
6EUCTR2012-002354-23-ES
(EUCTR)
05/06/201316/01/2014A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Lilly S.A.NULLNot Recruiting Female: yes
Male: yes
134 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Brazil;Poland;Belgium;Romania;Netherlands;Germany;Japan
7EUCTR2012-002354-23-AT
(EUCTR)
23/05/201301/03/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
35Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Netherlands;Japan
8EUCTR2012-002354-23-IT
(EUCTR)
12/04/201327/02/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
9EUCTR2011-001873-24-GB
(EUCTR)
29/03/201224/11/2011A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the bodyA multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: LY450190
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Other descriptive name: LY450190
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
24Phase 1;Phase 2United States;France;Canada;Spain;Poland;United Kingdom
10EUCTR2011-001873-24-ES
(EUCTR)
13/01/201226/10/2011A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the bodyA multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: LY450190
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Other descriptive name: LY450190
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
24Phase 1;Phase 2United States;France;Canada;Poland;Spain;United Kingdom
11EUCTR2009-011150-17-BE
(EUCTR)
15/11/201014/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
12EUCTR2009-011150-17-FR
(EUCTR)
24/09/201013/08/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
352 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
13EUCTR2009-011150-17-NL
(EUCTR)
26/08/201026/05/2010Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial HypertensionAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
545Germany;United Kingdom;Netherlands;France;Spain;Italy;Japan;Greece;Austria;Sweden
14EUCTR2009-011150-17-DE
(EUCTR)
16/08/201003/08/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden
15EUCTR2009-011150-17-GB
(EUCTR)
11/08/201022/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot Recruiting Female: yes
Male: yes
545 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
16EUCTR2009-011150-17-IT
(EUCTR)
06/08/201009/08/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Trade Name: VOLIBRIS
Trade Name: CIALIS
INN or Proposed INN: Tadalafil
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
17EUCTR2009-011150-17-AT
(EUCTR)
03/08/201022/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
18EUCTR2009-011150-17-GR
(EUCTR)
16/07/201014/07/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
19EUCTR2009-011150-17-SE
(EUCTR)
14/07/201018/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
20EUCTR2009-011150-17-ES
(EUCTR)
13/07/201002/06/2010AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Hipertensión arterial pulmonar
MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: CIALIS 20 mg comprimidos recubiertos con película
INN or Proposed INN: TADALAFILO
Other descriptive name: TADALAFIL
GlaxoSmithKline,S.A.NULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
21EUCTR2005-002844-24-GB
(EUCTR)
10/04/200612/09/2005A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGXA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Belgium;Ireland;Germany;Italy;United Kingdom
22EUCTR2005-002692-33-GB
(EUCTR)
10/04/200612/09/2005A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Belgium;Ireland;Germany;Italy;United Kingdom
23EUCTR2005-002844-24-ES
(EUCTR)
22/03/200612/12/2005- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerteTrade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Ireland;Spain;Italy
24EUCTR2005-002692-33-IE
(EUCTR)
23/02/200612/10/2005A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Belgium;Ireland;Germany;Italy;United Kingdom
25EUCTR2005-002844-24-IE
(EUCTR)
23/02/200612/10/2005A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGXA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Spain;Ireland;Italy
26EUCTR2005-002692-33-DE
(EUCTR)
17/02/200621/10/2005A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Product Name: Cialis
INN or Proposed INN: Tadalafil
Product Name: Cialis
INN or Proposed INN: Tadalafil
Product Name: Tadalafil
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Spain;Ireland;Germany;Italy;United Kingdom
27EUCTR2005-002692-33-ES
(EUCTR)
02/02/200612/12/2005Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYEstudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerteTrade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Belgium;Spain;Ireland;Germany;Italy;United Kingdom
28EUCTR2005-002692-33-BE
(EUCTR)
25/01/200626/10/2005A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Spain;Belgium;Ireland;Germany;Italy;United Kingdom
29EUCTR2005-002844-24-BE
(EUCTR)
25/01/200626/10/2005An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGXAn Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Eli Lilly and Company LimitedNULLNot RecruitingFemale: yes
Male: yes
350Phase 3;Phase 4Spain;Belgium;Ireland;Germany;Italy;United Kingdom
30EUCTR2005-002844-24-DE
(EUCTR)
17/01/200611/10/2005An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGXAn Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
350Spain;Ireland;Germany;Italy;United Kingdom
31EUCTR2011-001873-24-PL
(EUCTR)
09/12/2011A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the bodyA multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: LY450190
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Other descriptive name: LY450190
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
24Phase 1;Phase 2France;United States;Canada;Spain;Poland;United Kingdom
32EUCTR2012-002354-23-PL
(EUCTR)
17/06/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Brazil;Belgium;Romania;Germany;Netherlands;Japan
33EUCTR2012-002354-23-GB
(EUCTR)
16/01/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan