Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure (ADAM [Amlodipine and Dialysis Patients, Action on Mortality])|
- 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 ]
|Study Start Date:||January 2002|
|Study Completion Date:||October 2006|
Active Comparator: 1
Other Name: Placebo
Placebo Comparator: 2
Other Name: Placebo
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|Charite Campus Benjamin Franklin|
|Berlin, Germany, 12200|
|Principal Investigator:||Martin Tepel, Dr||Charite Campus Benjamin Franklin|