Status:
UNKNOWN
Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)
Lead Sponsor:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Kidney, Polycystic, Autosomal Dominant
Eligibility:
All Genders
20-60 years
Phase:
PHASE2
Brief Summary
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 e...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00890279
Start Date
July 1 2009
End Date
November 1 2012
Last Update
December 2 2009
Active Locations (9)
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1
Department of Urology, National Hospital Organaization Chiba-East Hospital
Chiba, Chiba, Japan, 2608712
2
Department of Medicine II, Hokkaido Univserity School of Medicine
Sapporo, Hokkaido, Japan, 0608638
3
Toranomon Hospital Kajigaya, Kidney center
Kawasaki, Kanagawa, Japan, 2138587
4
Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences
Niigata, Niigata, Japan, 9518510