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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2010

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.

Interventions

  • Drug: Cilnidipine
    • Cilnidipine up to 20 mg
  • Drug: Imidapril
    • Imidapril up to 10 mg per day

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • eGFR
    • Time Frame: every 6 months

Secondary Measures

  • Kidney Volume measured by MRI
    • Time Frame: every 3 months to every 2 years
  • Serum creatinine level
    • Time Frame: every 3 months to every 2 years
  • Induction of hemodialysis, cardiovascular events and central nervous vascular events
    • Time Frame: every 3 months to every 2 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ministry of Health, Labour and Welfare, Japan
  • Provider of Information About this Clinical Study
    • Shigeo Horie, M.D./Chairman of the Department of Urology at Teikyo University, Teikyo University, School of Medicine
  • Overall Official(s)
    • Shigeo Horie, MD, Study Chair, Teikyo University
  • Overall Contact(s)
    • Shigeo Horie, MD, +81339642497, shorie@med.teikyo-u.ac.jp

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