CCB Safety Study in Treatment of Hypertension of ADPKD
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ClinicalTrials.gov Identifier: NCT00541853 |
Recruitment Status : Unknown
Verified October 2007 by Kyorin University.
Recruitment status was: Not yet recruiting
First Posted : October 10, 2007
Last Update Posted : October 18, 2007
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Condition or disease | Intervention/treatment | Phase |
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Kidney, Polycystic, Autosomal Dominant | Drug: Candesartan Drug: Candesartan and Cilnidipine Drug: Candesartan plus non-CCB agents | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients |
Study Start Date : | December 2007 |
Estimated Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
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Active Comparator: A
ADPKD patients with blood pressure above 130/85 are enrolled. The patients whose blood pressure is controlled under 130/85 by Candesartan alone are classified into group A.
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Drug: Candesartan
Candesartan upto 8mg |
Experimental: B
The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group B, blood pressure is controlled by Candesartan plus Cilnidipine. If blood pressure is not lowered by Candesartan plus Cilnidipine alone, another antihypertensive agents except CCB and ACEI are allowable.
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Drug: Candesartan and Cilnidipine
Candesartan upto 8mg per day and Cilnidipine upto 20mg per day |
Active Comparator: C
The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group C, blood pressure is controlled by Candesartan plus non-CCB agents such as beta- or alpha- adrenergic blockers or another ARB. Any CCB and ACEI are not allowable.
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Drug: Candesartan plus non-CCB agents
Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI |
- Kidney Volume measured by MRI. [ Time Frame: Every year ]
- Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: any time during study period ]

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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 130/85 mmHg.
- Age between 20 and 60 years old.
- Plasma creatinine less than 2.0mg in man and 1.5mg in woman.
- 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): NCT00541853
Contact: Eiji Higashihara, M.D. | +81-422-47-5511 ext 5813 | ehigashi@kyorin-u.ac.jp |
Japan | |
Kyorin University School of Medicine | |
Mitaka, Tokyo, Japan, 181-8611 | |
Contact: Eiji Higashihara, M.D. 81+422475511 ext 5813 ehigashi@kyorin-u.ac.jp | |
Contact: Kikuo Nutahara, M.D. 81-422475511 ext 5815 kinuta@kyorin-u.ac.jp | |
Department of Urology, National Hospital Organaization Chiba-East Hospital | |
Chiba, Chiba, Japan, 260-8712 | |
Contact: Koichi Kamura, MD 81+432615171 ext 7607 kamura@cehpnet.com | |
Toranomon Hospital Kajigaya, Kidney center | |
Kanagawa, Japan, 213-8587 | |
Contact: Yoshifumi Ubara, MD 81+448775111 ext 6064 ubara@toranomon.gr.jp | |
Toranomon Hospital, Kidney center | |
Tokyo, Japan, 105-8470 | |
Contact: Kenmei Tkaichi, MD 81+335881111 ext 7065 takaichi@toranomon.gr.jp | |
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine | |
Tokyo, Japan, 105-8471 | |
Contact: Tatsuo Hosoya, MD 81+334331111 ext 3220 t-hosoya@jikei.ac.jp | |
Contact: Kazushige Hanaoka, MD 81+334331111 ext 3221 khanaoka@jikei.ac.jp | |
Department of Urology, Teikyo University, School of Medicine | |
Tokyo, Japan, 173-8605 | |
Contact: Shigeo Horie, MD 81+339641211 shorie@med.teikyo-u.ac.jp | |
Contact: Satoru Muto, MD 81+33964-1211 muto@med.teikyo-u.ac.jp |
Study Chair: | Eiji Higashihara, M.D. | Kyorin University, School of Medicine |
ClinicalTrials.gov Identifier: | NCT00541853 |
Other Study ID Numbers: |
ADPKDCCB |
First Posted: | October 10, 2007 Key Record Dates |
Last Update Posted: | October 18, 2007 |
Last Verified: | October 2007 |
Autosomal Dominant Polycystic Kidney Disease Hypertension Angiotensin-2 Receptor Blocker Calcium Channel Blocker Kidney Volume |
Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Congenital Abnormalities Kidney Diseases, Cystic Kidney Diseases Urologic Diseases Abnormalities, Multiple Ciliopathies Genetic Diseases, Inborn Candesartan |
Candesartan cilexetil Cilnidipine Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Physiological Effects of Drugs |