Status:
TERMINATED
SAFE-CRP: Structural Alterations and Function of Endothelium in Cardiovascular Risk Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Coronary Arteriosclerosis
Eligibility:
All Genders
36+ years
Phase:
PHASE4
Brief Summary
The aim of this trial is to evaluate the efficacy and safety of telmisartan 80 mg administered once daily in patients with documented coronary artery disease (CAD) and a probably cardiovascular risk p...
Detailed Description
Methodology: 2:1 randomised, double-blind and placebo-controlled parallel-group design Planned/actual number of subjects: Enrolled: 30/33, randomised: 30/22, completed: 30/15 Duration of treatment...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \> 35 years of age
- History of coronary artery disease (CAD)
- Ability to provide written informed consent
- Exclusion criteria:
- Pre-menopausal women (last menstruation \< 1 year prior to start of the screening visit) who:
- are not surgically sterile; and/or
- are nursing
- are of child-bearing potential and are NOT practising acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of \> 3-months duration. Acceptable methods of birth control include oral, implantable or injectable contraceptives
- Diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg at any visit during the study (run-in or randomised period)
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT(ALT) or SGOT(AST) \> than 2 times the upper limit of normal range
- Serum creatinine \> 2.3 mg/dL
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one kidney
- Clinically relevant hypokalaemia or hyperkalaemia
- Uncorrected volume depletion
- Uncorrected sodium depletion
- Primary aldosteronism
- Hereditary fructose intolerance
- Biliary obstructive disorders
- Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
- History of drug or alcohol dependency within 6 months
- Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol
- Any investigational therapy within one month of signing the informed consent form
- Known hypersensitivity to any component of the formulation
- Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan
- Stroke within the last 6 months
- Myocardial infarction within the last 30 days
- Cardiac surgery within the last 3 months
- Hyperthyroidosis
- Hemodynamically relevant valvular disease
- Restrictive hypertrophic cardiomyopathy
- Unstable angina pectoris
- CAD with the indication of bypass surgery.
Exclusion
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00274105
Start Date
March 1 2001
End Date
October 1 2004
Last Update
January 23 2025
Active Locations (2)
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1
Universitätsklinikum Charité
Berlin, Germany, 10117
2
Med. Hochschule Hannover
Hanover, Germany, 30623