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

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

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Labour and Welfare, Japan
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Cilnidipine; Imidapril

Criteria

Inclusion Criteria:

• ADPKD patients

• Blood pressure measured at out-patient setting is above 120/80 mmHg

• Age between 20 and 60 years old

• eGFR more than 30 ml/min/1.73m2

• 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