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Sponsored by: |
Charite University, Berlin, Germany |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00124969 |
Patients with end-stage renal failure have a markedly higher mortality because of cardiovascular events in comparison with the normal population. Disorders in the calcium metabolism, such as calcification of the vessel walls, occur very frequently. There are indications that calcium channel blockers are capable of lowering the cardiovascular mortality in patients with end-stage renal failure.
It is intended to carry out a prospective, randomized, double-blind, placebo-controlled, multicenter study in order to find out if the calcium channel blocker amlodipine is able to reduce the mortality of patients with end-stage renal failure.
The investigation will be carried out after suitable explanation and written informed consent in 356 patients aged between 18 and 90 years with end-stage renal failure and chronic haemodialysis treatment. The patients will be randomized to either treatment with amlodipine 10 mg/day or placebo. The occurrence of events will be documented and evaluated prospectively over a period of 30 months.
Condition | Intervention | Phase |
---|---|---|
Kidney Failure, Chronic |
Drug: Amlodipine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure (ADAM [Amlodipine and Dialysis Patients, Action on Mortality]) |
Enrollment: | 356 |
Study Start Date: | January 2002 |
Study Completion Date: | October 2006 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Amlodipine
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Drug: Amlodipine
10mg
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2: Placebo Comparator
Placebo
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Drug: Placebo
10mg
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Charite Campus Benjamin Franklin | |
Berlin, Germany, 12200 |
Principal Investigator: | Martin Tepel, Dr | Charite Campus Benjamin Franklin |
Study ID Numbers: | ADAM, AML-D-01-001G |
Study First Received: | June 30, 2005 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00124969 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
End-stage renal disease, hemodialysis |
Calcium, Dietary Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Amlodipine Kidney Failure |
Membrane Transport Modulators Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |