CCB Safety Study in Treatment of Hypertension of ADPKD

• Status: Unknown status
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyorin University
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Candesartan; Candesartan cilexetil; Cilnidipine

Criteria

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.