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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124969
First Posted: July 29, 2005
Last Update Posted: May 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00124969     History of Changes
Other Study ID Numbers: ADAM
AML-D-01-001G
First Submitted: June 30, 2005
First Posted: July 29, 2005
Last Update Posted: May 9, 2008
Last Verified: October 2006

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
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents