Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00890279 |
Recruitment Status
: Unknown
Verified December 2009 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was: Recruiting
First Posted
: April 29, 2009
Last Update Posted
: December 2, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney, Polycystic, Autosomal Dominant | Drug: Cilnidipine Drug: Imidapril | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | July 2009 |
Estimated Primary Completion Date : | June 2010 |
Estimated Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
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
|
- eGFR [ Time Frame: every 6 months ]
- Kidney Volume measured by MRI [ Time Frame: every 3 months to every 2 years ]
- Serum creatinine level [ Time Frame: every 3 months to every 2 years ]
- Induction of hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: every 3 months to every 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ADPKD patients
- Blood pressure measured at out-patient setting is above 120/80 mmHg
- Age between 20 and 60 years old
- eGFR more than 30 ml/min/1.73m2
- Patients give informed consent
Exclusion Criteria:
- Patients with severe cardiovascular and hepatic disorders
- Patients with complications of central nervous vascular disorders
- Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
- Patients currently engaging in other experimental protocol
- Patients with intracranial aneurysma
- Patients who must use diuretics
- Allergic patients to Candesartan or Cilnidipine
- Patients whose hypertension is not controlled by medication of this protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890279
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 | |
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 | |
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine | Active, not recruiting |
Minato-ku, Tokyo, Japan, 1058471 | |
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 |
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 |
First Posted: | April 29, 2009 Key Record Dates |
Last Update Posted: | December 2, 2009 |
Last Verified: | December 2009 |
Keywords provided by Ministry of Health, Labour and Welfare, Japan:
Autosomal Dominant Polycystic Kidney Disease Hypertension Angiotensin-II Receptor Blocker Calcium Channel Blocker |
Angiotensin converting enzyme inhibitor Kidney Volume eGFR |
Additional relevant MeSH terms:
Hypertension Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Vascular Diseases Cardiovascular Diseases Urologic Diseases Kidney Diseases, Cystic Abnormalities, Multiple Congenital Abnormalities |
Genetic Diseases, Inborn Angiotensin-Converting Enzyme Inhibitors Imidapril Cilnidipine Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Membrane Transport Modulators Antihypertensive Agents |