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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00124969
First received: June 30, 2005
Last updated: May 7, 2008
Last verified: October 2006
History of Changes
  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 4

Study Type: Interventional
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])

Resource links provided by NLM:

U.S. FDA Resources

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
Active Comparator: 1
Amlodipine
 Drug: Amlodipine
10mg
Other Name: Placebo
Placebo Comparator: 2
Placebo
 Drug: Placebo
10mg
Other Name: Placebo

  Show Detailed Description

  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:

ClinicalTrials.gov Identifier: NCT00124969     History of Changes
Other Study ID Numbers: ADAM, AML-D-01-001G
Study First Received: June 30, 2005
Last Updated: May 7, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
End-stage renal disease, hemodialysis

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Amlodipine
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2013