67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details
臨床試験数 : 221 / 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03541447 (ClinicalTrials.gov) | December 12, 2018 | 17/5/2018 | Tolvaptan-Octreotide LAR Combination in ADPKD | A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan;Drug: Octreotide LAR;Other: Placebo | Mario Negri Institute for Pharmacological Research | Otsuka Pharmaceutical Italy S.r.l. | Completed | 18 Years | N/A | All | 20 | Phase 2 | Italy |
| 2 | EUCTR2017-004701-40-IT (EUCTR) | 06/08/2018 | 26/09/2019 | STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION | A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD | Autosomal Dominant Policiytic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI Product Name: sandostatina LAR Product Code: sandostatina | IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 3 | NCT01377246 (ClinicalTrials.gov) | May 2011 | 20/6/2011 | Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency | A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCY | Autosomal Dominant Polycystic Kidney Disease | Drug: Octreotide-LAR;Other: Saline solution. | Mario Negri Institute for Pharmacological Research | NULL | Completed | 18 Years | 75 Years | All | 100 | Phase 3 | Italy |
| 4 | EUCTR2011-000138-12-IT (EUCTR) | 04/04/2011 | 28/12/2011 | A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2 | A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2 | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: SANDOSTATINA LAR INN or Proposed INN: Octreotide | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy | ||
| 5 | EUCTR2009-012376-27-IT (EUCTR) | 16/11/2009 | 30/11/2009 | EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN II | EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN II | Polycystic Kidney MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Trade Name: SANDOSTATINA LAR INN or Proposed INN: Octreotide | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | Italy | ||
| 6 | NCT00426153 (ClinicalTrials.gov) | January 2007 | 22/1/2007 | Octreotide in Severe Polycystic Liver Disease | Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease | Polycystic Kidney, Autosomal Dominant;Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Kidney, Polycystic;Abdominal Pain | Drug: Octreotide;Drug: Placebo | Mayo Clinic | Novartis;National Center for Research Resources (NCRR) | Completed | 18 Years | 80 Years | All | 42 | Phase 2/Phase 3 | United States |
| 7 | EUCTR2005-005552-41-IT (EUCTR) | 20/02/2006 | 06/03/2007 | Effect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADIN | Effect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADIN | Autosomal Dominant Polycystic Kidney Disease ADPKD MedDRA version: 6.1;Level: SOC;Classification code 10038359 | Trade Name: Sandostatina Lar IM Fl 20mg +2F Product Name: octreotide INN or Proposed INN: Octreotide | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy |