NCT00890279

Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)

Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Ministry of Health, Labour and Welfare, Japan · Other Government
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB) alone.

Detailed description

Maximum dosage of candesartan is 8 mg/day. Dosage of imidapril is in the range of 2.5-10 mg/day. Dosage of cilnidipine is in the range of 5-20mg/day.

Conditions

• Kidney, Polycystic, Autosomal Dominant

Interventions

Type	Name	Description
DRUG	Cilnidipine	Cilnidipine up to 20 mg
DRUG	Imidapril	Imidapril up to 10 mg per day

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-06-01
• Completion: 2012-11-01
• First posted: 2009-04-29
• Last updated: 2009-12-02

Locations

9 sites across 1 country: Japan