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CCB Safety Study in Treatment of Hypertension of ADPKD

NCT00541853 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2007-10-18

No results posted yet for this study

Summary

This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.

Conditions

  • Kidney, Polycystic, Autosomal Dominant

Interventions

DRUG

Candesartan

Candesartan upto 8mg

DRUG

Candesartan and Cilnidipine

Candesartan upto 8mg per day and Cilnidipine upto 20mg per day

DRUG

Candesartan plus non-CCB agents

Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI

Sponsors & Collaborators

  • Ministry of Health, Labour and Welfare, Japan

    collaborator OTHER_GOV

  • Kyorin University

    lead OTHER

Principal Investigators

  • Eiji Higashihara, M.D. · Kyorin University, School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Completion
2012-11-30

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00541853 on ClinicalTrials.gov