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

Ministry of Health, Labour and Welfare, Japan

Status and phase: Unknown; Phase 2

Conditions: Kidney, Polycystic, Autosomal Dominant

Treatments: Drug: Imidapril; Drug: Cilnidipine

Study type: Interventional

Funder types: Other

Identifiers

NCT00890279

ADPKDhypertension

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

Cilnidipine

Experimental group

Description:

The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group A, blood pressure is controlled by Candesartan plus Cilnidipine.

Treatment:

Drug: Cilnidipine

Imidapril

Active Comparator group

Description:

The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group B, blood pressure is controlled by Candesartan plus Imidapril.

Treatment:

Drug: Imidapril