Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i
NCT ID: NCT00750308
Last Updated: 2014-12-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2006-12-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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tadalafil, ramapril, combo, placebo
placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril + tadalafil, washout, placebo+placebo for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
ramipril, tadalafil, placebo, combo
placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
combo, placebo, tadalafil, ramipril
ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
placebo, combo, ramipril, tadalafil
placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
tadalafil, placebo, ramipril, combo
placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
ramipril, combo, tadalfil, placebo
placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
combo, ramipril, placebo, tadalafil
ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
placebo, tadalafil, combo, ramipril
placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
tadalafil, combo, placebo, ramipril
placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
ramipril, placebo, combo, tadalafil
placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
combo, tadalafil, ramipril, placebo
ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
placebo, ramipril, tadalafil, combo
placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks
Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
Interventions
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Ramipril
Ramipril 10 mg per day for three weeks
Tadalafil
tadalafil 10 mg every other day for three weeks
placebo
placebo matching ramipril
placebo
placebo matching tadalafil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. For female subjects, the following conditions must be met:
* Postmenopausal status for at least 1 year,
* Status-post surgical sterilization, or
* If of childbearing potential, utilization of adequate birth control, and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day
3. Metabolic syndrome as defined by 3 or more of the following:
* Fasting plasma glucose of at least 100 mg/dL (5.5 mmol/L),
* Serum triglycerides of at least 150 mg/dL (1.7 mmol/L),
* Serum HDL cholesterol less than 40 mg/dL (1.04 mmol/L) in males and less than 50mg/dl (1.30mmol/L) in females,
* Blood pressure of at least 130/85 mmHg, or
* Waist girth of more than 102 cm in men or 88 cm in women
Exclusion Criteria
1. Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater or the use of anti-diabetic medication
2. Use of hormone replacement therapy
3. Statin therapy
4. In hypertensive subjects, a seated systolic blood pressure greater than 179 mmHg or a seated diastolic blood pressure greater than 110 mmHg
5. Pregnancy
6. Breast-feeding
7. Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
8. Treatment with anticoagulants
9. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
10. History or presence of immunological or hematological disorders
11. Diagnosis of asthma
12. Clinically significant gastrointestinal impairment that could interfere with drug absorption
13. Impaired hepatic function (aspartate amino transaminase \[AST\] and/or alanine amino transaminase \[ALT\] \> 1.5 x upper limit of normal range)
14. Impaired renal function (serum creatinine \> 1.5 mg/dl)
15. Hematocrit \< 35%
16. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
17. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
18. Treatment with lithium salts
19. History of alcohol or drug abuse
20. Treatment with any investigational drug in the 1 month preceding the study
21. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
22. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
18 Years
70 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Vanderbilt University
OTHER
Responsible Party
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Nancy J. Brown
Professor of Medicine
Principal Investigators
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Nancy J Brown, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Other Identifiers
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060198
Identifier Type: -
Identifier Source: org_study_id