CCB Safety Study in Treatment of Hypertension of ADPKD

October 17, 2007 updated by: Kyorin University

Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Chiba, Chiba, Japan, 260-8712
        • Department of Urology, National Hospital Organaization Chiba-East Hospital
        • Contact:
      • Kanagawa, Japan, 213-8587
        • Toranomon Hospital Kajigaya, Kidney center
        • Contact:
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital, Kidney center
        • Contact:
      • Tokyo, Japan, 105-8471
        • Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
        • Contact:
        • Contact:
      • Tokyo, Japan, 173-8605
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Kidney Volume measured by MRI.
Time Frame: Every year
Every year

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events
Time Frame: any time during study period
any time during study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyorin University

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Eiji Higashihara, M.D., Kyorin University, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (ANTICIPATED)

November 1, 2012

Study Registration Dates

First Submitted

October 9, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (ESTIMATE)

October 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2007

Last Update Submitted That Met QC Criteria

October 17, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADPKDCCB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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