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| Sponsor: | Ministry of Health, Labour and Welfare, Japan |
|---|---|
| Information provided by: | Ministry of Health, Labour and Welfare, Japan |
| ClinicalTrials.gov Identifier: | NCT00890279 |
Purpose
This phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB) alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney, Polycystic, Autosomal Dominant |
Drug: Cilnidipine Drug: Imidapril |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB |
| Estimated Enrollment: | 160 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cilnidipine
The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group A, blood pressure is controlled by Candesartan plus Cilnidipine.
|
Drug: Cilnidipine
Cilnidipine up to 20 mg
Other Name: ATELEC
|
|
Active Comparator: Imidapril
The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group B, blood pressure is controlled by Candesartan plus Imidapril.
|
Drug: Imidapril
Imidapril up to 10 mg per day
Other Name: TANATRIL
|
Maximum dosage of candesartan is 8 mg/day. Dosage of imidapril is in the range of 2.5-10 mg/day. Dosage of cilnidipine is in the range of 5-20mg/day.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shigeo Horie, MD | +81339642497 | shorie@med.teikyo-u.ac.jp |
| Contact: Satoru Muto, MD, PhD | +81339642497 | muto@med.teikyo-u.ac.jp |
| Japan | |
| Department of Medicine II, Hokkaido Univserity School of Medicine | Recruiting |
| Sapporo, Hokkaido, Japan, 0608638 | |
| Contact: Toshio Mochizuki, MD +81117065915 mtoshi@med.hokudai.ac.jp | |
| Principal Investigator: Toshio Mochizuki, MD | |
| Toranomon Hospital Kajigaya, Kidney center | Not yet recruiting |
| Kawasaki, Kanagawa, Japan, 2138587 | |
| Contact: Yoshihumi Ubara, MD +81448775111 ext 6064 ubara@toranomon.gr.jp | |
| Principal Investigator: Yoshihumi Ubara, MD | |
| Department of Medicine II, Nippon Medical School | Not yet recruiting |
| Bunkyo-ku, Tokyo, Japan, 1138602 | |
| Contact: Yasuhiko Iino, MD +81338222131 iinoyasuhiko@nms.ac.jp | |
| Principal Investigator: Yasuhiko Iino, MD | |
| Department of Urology, Teikyo University School of Medicine | Recruiting |
| Itabashi-ku, Tokyo, Japan, 1738605 | |
| Contact: Shigeo Horie, MD +81339642497 shorie@med.teikyo-u.ac.jp | |
| Contact: Satoru Muto, MD +81339642497 muto@med.teikyo-u.ac.jp | |
| Principal Investigator: Shigeo Horie, MD | |
| Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine | Active, not recruiting |
| Minato-ku, Tokyo, Japan, 1058471 | |
| Toranomon Hospital, Kidney center | Not yet recruiting |
| Minato-ku, Tokyo, Japan, 1058470 | |
| Contact: Kenmei Takaichi, MD +81335881111 ext 7065 takaichi@toranomon.gr.jp | |
| Principal Investigator: Kenmei Takaichi, MD | |
| Department of Urology, Kyorin University School of Medicine | Not yet recruiting |
| Mitaka, Tokyo, Japan, 1818611 | |
| Contact: Eiji HIgashihara, MD 81422475511 ehigashi@kyorin-u.ac.jp | |
| Contact: Kikuo Nutahara, MD 81422475511 kinuta@kyorin-u.ac.jp | |
| Principal Investigator: Eiji Higashihara, MD | |
| Sub-Investigator: Kikuo Nutahara, MD | |
| Department of Urology, National Hospital Organaization Chiba-East Hospital | Not yet recruiting |
| Chiba, Japan, 2608712 | |
| Contact: Koichi Kamura, MD +81432615171 ext 7607 kamura@cehpnet.com | |
| Principal Investigator: Koichi Kamura, MD | |
| Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences | Not yet recruiting |
| Niigata, Japan, 9518510 | |
| Contact: Ichiei Narita, MD +813252272193 naritai@med.niigata-u.ac.jp | |
| Principal Investigator: Ichiei Narita, MD | |
| Study Chair: | Shigeo Horie, MD | Teikyo University |
More Information
| Responsible Party: | Shigeo Horie, M.D./Chairman of the Department of Urology at Teikyo University, Teikyo University, School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00890279 History of Changes |
| Other Study ID Numbers: | ADPKDhypertension |
| Study First Received: | April 28, 2009 |
| Last Updated: | December 1, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Autosomal Dominant Polycystic Kidney Disease Hypertension Angiotensin-II Receptor Blocker Calcium Channel Blocker |
Angiotensin converting enzyme inhibitor Kidney Volume eGFR |
|
Hypertension Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Vascular Diseases Cardiovascular Diseases Urologic Diseases Kidney Diseases, Cystic Angiotensin-Converting Enzyme Inhibitors Imidapril Calcium Channel Blockers |
Cilnidipine Angiotensin Receptor Antagonists Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Membrane Transport Modulators Cardiovascular Agents Therapeutic Uses Antihypertensive Agents |
