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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT00890279
First received: April 28, 2009
Last updated: December 1, 2009
Last verified: December 2009

April 28, 2009
December 1, 2009
July 2009
June 2010   (final data collection date for primary outcome measure)
eGFR [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00890279 on ClinicalTrials.gov Archive Site
  • Kidney Volume measured by MRI [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]
  • Serum creatinine level [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]
  • Induction of hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)
Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney, Polycystic, Autosomal Dominant
  • Drug: Cilnidipine
    Cilnidipine up to 20 mg
    Other Name: ATELEC
  • Drug: Imidapril
    Imidapril up to 10 mg per day
    Other Name: TANATRIL
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: Imidapril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
November 2012
June 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact: Shigeo Horie, MD +81339642497 shorie@med.teikyo-u.ac.jp
Contact: Satoru Muto, MD, PhD +81339642497 muto@med.teikyo-u.ac.jp
Japan
 
NCT00890279
ADPKDhypertension
No
Shigeo Horie, M.D./Chairman of the Department of Urology at Teikyo University, Teikyo University, School of Medicine
Ministry of Health, Labour and Welfare, Japan
Not Provided
Study Chair: Shigeo Horie, MD Teikyo University
Ministry of Health, Labour and Welfare, Japan
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP