CCB Safety Study in Treatment of Hypertension of ADPKD

Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00541853

Enrollment

150

Registered

2007-10-10

Start date

2007-12-31

Completion date

2012-11-30

Last updated

2007-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney, Polycystic, Autosomal Dominant

Keywords

Autosomal Dominant Polycystic Kidney Disease, Hypertension, Angiotensin-2 Receptor Blocker, Calcium Channel Blocker, Kidney Volume

Brief 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.

Interventions

DRUGCandesartan

Candesartan upto 8mg

DRUGCandesartan and Cilnidipine

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

DRUGCandesartan plus non-CCB agents

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

* ADPKD patients. * Blood pressure measured at out-patient setting is above 130/85 mmHg. * Age between 20 and 60 years old. * Plasma creatinine less than 2.0mg in man and 1.5mg in woman. * 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.

Design outcomes

Primary

Measure	Time frame
Kidney Volume measured by MRI.	Every year

Secondary

Measure	Time frame
Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events	any time during study period

Countries

Japan

Contacts

Primary ContactEiji Higashihara, M.D.

ehigashi@kyorin-u.ac.jp+81-422-47-5511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026