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NCT00005928 · ClinicalTrials.gov registry record · Phase 2
Effects of Angiotensin-Converting Enzyme Inhibitor (Ramipril) Therapy on Blood Vessel Inflammation
A Phase 2 study of Atherosclerosis and Coronary Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00005928 is a Phase 2 study of Atherosclerosis and Coronary Disease that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 25 participants, below the 1,065-participant average among 69 other Atherosclerosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00005928, a Phase 2 study of Atherosclerosis and Coronary Disease, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine the effects of angiotensin-converting enzyme (ACE) inhibitor (trade name Ramipril) therapy on inflammation and stiffness of artery walls. These are two risk factors for developing atherosclerosis-deposits of fatty substances called plaques that can block the blood vessel, causing a heart attack or stroke. Studies of patients with coronary artery disease suggest that ACE inhibitor therapy reduces the risk of heart attack and heart failure. This study will examine the effects of this treatment on the artery walls and on levels of substances in the blood that indicate blood vessel inflammation. Patients between 40 and 75 years old with coronary artery disease caused by atherosclerosis may be eligible for this study. Candidates will be screened with a medical history, cardiovascular (heart and blood vessel) examination, electrocardiogram and blood tests. Those enrolled will be randomly assigned to take either an ACE inhibitor pill or a placebo (look-alike pill with no medicine) once a day for 3 months. No pills will be taken for the next month, and then participants will take the alternate pill for the next 3 months. That is, those who took ACE inhibitor for the first 3-month period will take placebo for the second 3-month period and vice versa. Blood pressures will be taken at the NIH Clinical Center or by the patient's physician at the end of the first and second weeks of the study. At the end of 3 weeks, patients will return to the Clinical Center for a blood draw of 6 cc (1/2 teaspoon) to assess kidney function. In addition, at the end of each 3-month study period, patients will undergo the following procedures at the Clinical Center: 1. Fasting blood draw of 60 cc (2 ounces) to measure electrolytes (e.g., sodium and potassium) and blood markers for inflammation 2. Ultrasound (use of sound waves to create pictures) study of the carotid arteries (arteries in the neck leading to the brain)-An ultrasound probe is applied gently on the neck,
Conditions Studied
Interventions
- DRUG Ramipril
Study Locations (1)
Maryland
- National Heart, Lung and Blood Institute (NHLBI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2000-06 |
| Est. Completion | 2002-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005928
The ClinicalTrials.gov registry entry for NCT00005928 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,065-participant average among 69 other Atherosclerosis trials with a reported enrollment target (98% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Atherosclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ramipril is the first listed.
NCT00005928 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00005928 about?
NCT00005928 is a clinical study titled "Effects of Angiotensin-Converting Enzyme Inhibitor (Ramipril) Therapy on Blood Vessel Inflammation". This study will determine the effects of angiotensin-converting enzyme (ACE) inhibitor (trade name Ramipril) therapy on inflammation and stiffness of artery walls. These are two risk factors for developing atherosclerosis-deposits of fatty substances called plaques that can block the blood vessel, c...
What is the current status of trial NCT00005928?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2000-06. Estimated completion is 2002-02.
What conditions does trial NCT00005928 study?
This clinical trial studies the following conditions: Atherosclerosis, Coronary Disease, Vasculitis.
What interventions are being tested in trial NCT00005928?
The interventions under investigation include: Ramipril (DRUG).
Who is sponsoring clinical trial NCT00005928?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00005928 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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