Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT00274105
Eligibility Criteria:
Inclusion criteria:
1. \> 35 years of age
2. History of coronary artery disease (CAD)
3. Ability to provide written informed consent
Exclusion criteria:
1. Pre-menopausal women (last menstruation \< 1 year prior to start of the screening visit) who:
1. are not surgically sterile; and/or
2. are nursing
3. 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
2. Diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg at any visit during the study (run-in or randomised period)
3. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
1. SGPT(ALT) or SGOT(AST) \> than 2 times the upper limit of normal range
2. Serum creatinine \> 2.3 mg/dL
4. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one kidney
5. Clinically relevant hypokalaemia or hyperkalaemia
6. Uncorrected volume depletion
7. Uncorrected sodium depletion
8. Primary aldosteronism
9. Hereditary fructose intolerance
10. Biliary obstructive disorders
11. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
12. History of drug or alcohol dependency within 6 months
13. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol
14. Any investigational therapy within one month of signing the informed consent form
15. Known hypersensitivity to any component of the formulation
16. 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
17. Stroke within the last 6 months
18. Myocardial infarction within the last 30 days
19. Cardiac surgery within the last 3 months
20. Hyperthyroidosis
21. Hemodynamically relevant valvular disease
22. Restrictive hypertrophic cardiomyopathy
23. Unstable angina pectoris
24. CAD with the indication of bypass surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Years
Study:
NCT00274105
Study Brief:
Protocol Section:
NCT00274105