NCT00541853

CCB Safety Study in Treatment of Hypertension of ADPKD

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Kyorin University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney, Polycystic, Autosomal Dominant

Interventions

Type	Name	Description
DRUG	Candesartan	Candesartan upto 8mg
DRUG	Candesartan and Cilnidipine	Candesartan upto 8mg per day and Cilnidipine upto 20mg per day
DRUG	Candesartan plus non-CCB agents	Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI

Timeline

• Start date: 2007-12-01
• Completion: 2012-11-01
• First posted: 2007-10-10
• Last updated: 2007-10-18

Locations

6 sites across 1 country: Japan