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CCB Safety Study in Treatment of Hypertension of ADPKD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Kyorin University.
Recruitment status was:  Not yet recruiting
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Kyorin University Identifier:
First received: October 9, 2007
Last updated: October 17, 2007
Last verified: October 2007
This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.

Condition Intervention Phase
Kidney, Polycystic, Autosomal Dominant
Drug: Candesartan
Drug: Candesartan and Cilnidipine
Drug: Candesartan plus non-CCB agents
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • Kidney Volume measured by MRI. [ Time Frame: Every year ]

Secondary Outcome Measures:
  • Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: any time during study period ]

Estimated Enrollment: 150
Study Start Date: December 2007
Estimated Study Completion Date: November 2012
Arms Assigned Interventions
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.
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.
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.
Drug: Candesartan plus non-CCB agents
Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00541853

Kyorin University School of Medicine
Mitaka, Tokyo, Japan, 181-8611
Department of Urology, National Hospital Organaization Chiba-East Hospital
Chiba, Chiba, Japan, 260-8712
Toranomon Hospital Kajigaya, Kidney center
Kanagawa, Japan, 213-8587
Toranomon Hospital, Kidney center
Tokyo, Japan, 105-8470
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Tokyo, Japan, 105-8471
Department of Urology, Teikyo University, School of Medicine
Tokyo, Japan, 173-8605
Sponsors and Collaborators
Kyorin University
Ministry of Health, Labour and Welfare, Japan
Study Chair: Eiji Higashihara, M.D. Kyorin University, School of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00541853     History of Changes
Other Study ID Numbers: ADPKDCCB 
Study First Received: October 9, 2007
Last Updated: October 17, 2007

Keywords provided by Kyorin University:
Autosomal Dominant Polycystic Kidney Disease
Angiotensin-2 Receptor Blocker
Calcium Channel Blocker
Kidney Volume

Additional relevant MeSH terms:
Polycystic Kidney, Autosomal Dominant
Polycystic Kidney Diseases
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Candesartan cilexetil
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on February 20, 2017