Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure - Full Text View

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00124969

Purpose

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

MedlinePlus related topics: Calcium Kidney Failure

Drug Information available for: Amlodipine Amlodipine besylate

U.S. FDA Resources

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])

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

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 ]

Enrollment:	356
Study Start Date:	January 2002
Study Completion Date:	October 2006

Arms	Assigned Interventions
1: Active Comparator Amlodipine	Drug: Amlodipine 10mg
2: Placebo Comparator Placebo	Drug: Placebo 10mg

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Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124969

Locations

Germany
Charite Campus Benjamin Franklin
Berlin, Germany, 12200

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Martin Tepel, Dr

Charite Campus Benjamin Franklin

More Information

Publications:

Tepel M, Giet MV, Park A, Zidek W. Association of calcium channel blockers and mortality in haemodialysis patients. Clin Sci (Lond). 2002 Nov;103(5):511-5.

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

Keywords provided by Charite University, Berlin, Germany:

End-stage renal disease, hemodialysis

Study placed in the following topic categories:

Calcium, Dietary
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Amlodipine
Kidney Failure

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009