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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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

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Kidney, Polycystic, Autosomal Dominant

Keywords

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Autosomal Dominant Polycystic Kidney Disease Hypertension Angiotensin-II Receptor Blocker Calcium Channel Blocker Angiotensin converting enzyme inhibitor Kidney Volume eGFR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cilnidipine

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.

Group Type EXPERIMENTAL

Cilnidipine

Intervention Type DRUG

Cilnidipine up to 20 mg

Imidapril

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.

Group Type ACTIVE_COMPARATOR

Imidapril

Intervention Type DRUG

Imidapril up to 10 mg per day

Interventions

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Cilnidipine

Cilnidipine up to 20 mg

Intervention Type DRUG

Imidapril

Imidapril up to 10 mg per day

Intervention Type DRUG

Other Intervention Names

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ATELEC TANATRIL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Teikyo University, School of Medicine

Principal Investigators

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Shigeo Horie, MD

Role: STUDY_CHAIR

Teikyo University

Locations

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