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NCT00004575 · ClinicalTrials.gov registry record · Phase 1
Effects of Miconazole on Blood Flow
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00004575 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 15 participants.
The verdict
NCT00004575, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will investigate the effect of the drug miconazole on blood vessel dilation. Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is produced by the cells that line blood vessels. Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will be screened for eligibility with a medical history, physical examination, electrocardiogram and routine laboratory tests. Those enrolled will be injected with miconazole to study its effects on blood vessels. Study participants will take three aspirin tablets. After administration of a local anesthetic, small tubes will be inserted through a needle into the artery and vein of the forearm. These will be used to measure blood pressure and to draw blood samples during the study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement will be recorded. Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure. Miconazole is commonly prescribed to treat various infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys, or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the lining cells of blood vessels. Blood flow will be measured throughout the study, which will last approximately 3 hours.
Interventions
- DRUG Miconazole, L-NMMA, Bradykinin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2000-02 |
| Est. Completion | 2001-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004575
The ClinicalTrials.gov registry entry for NCT00004575 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which Miconazole, L-NMMA, Bradykinin is the first listed.
NCT00004575 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00004575 about?
NCT00004575 is a clinical study titled "Effects of Miconazole on Blood Flow". This study will investigate the effect of the drug miconazole on blood vessel dilation. Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is produced by the cells that line blood vessels. Normal volunteers between the ages of 21 to 60 may participate in this stud...
What is the current status of trial NCT00004575?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2000-02. Estimated completion is 2001-10.
What interventions are being tested in trial NCT00004575?
The interventions under investigation include: Miconazole, L-NMMA, Bradykinin (DRUG).
Who is sponsoring clinical trial NCT00004575?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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