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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00890279 |
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Date of registration:
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28/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)
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Scientific title:
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Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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160 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00890279 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shigeo Horie, MD |
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Address:
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Telephone:
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+81339642497 |
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Email:
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shorie@med.teikyo-u.ac.jp |
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Affiliation:
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Name:
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Shigeo Horie, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Teikyo University |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney, Polycystic, Autosomal Dominant
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Intervention(s)
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Drug: Imidapril
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Drug: Cilnidipine
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Primary Outcome(s)
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eGFR
[Time Frame: every 6 months]
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Secondary Outcome(s)
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Kidney Volume measured by MRI
[Time Frame: every 3 months to every 2 years]
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Serum creatinine level
[Time Frame: every 3 months to every 2 years]
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Induction of hemodialysis, cardiovascular events and central nervous vascular events
[Time Frame: every 3 months to every 2 years]
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Secondary ID(s)
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ADPKDhypertension
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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