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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00124969 |
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Date of registration:
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30/06/2005 |
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Primary sponsor: |
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Public title:
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Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure
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Scientific title:
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Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure (ADAM [Amlodipine and Dialysis Patients, Action on Mortality]) |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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356 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00124969 |
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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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Martin Tepel, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charite Campus Benjamin Franklin |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- End-stage renal disease
- Hemodialysis
- Hypertension
- Written informed consent
Exclusion Criteria:
- Hypotension of less than 90 mmHg systolic
- High-grade aortic stenosis
- Heart failure of NYHA stage III and IV
- Acute myocardial infarction (within the last 4 weeks)
- Acute heart failure
- Known allergy to the medicament amlodipine or other constituents of the medicament
- Severe disorders of liver function
- Pregnancy and breast-feeding
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Failure, Chronic
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Intervention(s)
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Drug: Amlodipine
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Drug: Placebo
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Primary Outcome(s)
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The primary outcome will be the survival rate. The secondary outcome will be cardiovascular events.
[Time Frame: Prospective: look forward using periodic observations collected predominantly following subject enrollment]
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Secondary ID(s)
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ADAM
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AML-D-01-001G
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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