Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00508989 · ClinicalTrials.gov registry record · Phase 2
Niacin to Improve Blood Flow in People With Sickle Cell Disease
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00508989 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 30 participants.
The verdict
NCT00508989, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will determine whether niacin can improve blood flow in people with sickle cell disease, in which abnormal red blood cells interfere with blood flow to cause the disease symptoms. Niacin, a drug that has been used to increase HDL (good cholesterol) levels, improves blood flow in people without sickle cell disease. This study will see if it can do the same in people with the disease. Patients with sickle cell disease between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, echocardiogram and 6-minute walk test of exercise capacity. Participants have the following baseline blood flow studies: * Flow-mediated dilation (FMD): An ultrasound picture of the artery in the forearm is obtained. A blood pressure cuff is then placed on the upper arm and inflated for 5 minutes. After the pressure cuff is released, the ultrasound is repeated. * Peripheral artery tonometry (PAT): A sensor is placed on the subject s finger. The sensor puts pressure on the finger and measures blood flow. * Standard forearm blood flow test: Small tubes are placed in the artery of the forearm at the inside of the elbow. Saline is infused into one tube. Pressure cuffs are applied to the wrist and upper arm. A strain gauge (rubber band device) is placed around the forearm. When the cuffs are inflated, blood flows into the arm, stretching the strain gauge, and the flow measurement is recorded. Blood samples are collected from the tube in the artery to measure blood counts, proteins and other chemicals. At various times, small doses of the following drugs are administered through the tube in the vein: * Sodium nitroprusside causes blood vessels to dilate and increases blood flow to the heart. * Acetylcholine causes blood vessels to dilate and slows heart rate. * LNMMA decreases blood flow by blocking the production of nitric oxide. Blood flow is measured after each dose of the different drugs. T
Interventions
- DRUG Placebo
- DRUG Acetylcholine
- DRUG L-NMMA
- DRUG Niacin-ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-07-24 |
| Est. Completion | 2015-12-24 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00508989
The ClinicalTrials.gov registry entry for NCT00508989 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 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 4 interventions - of which Placebo is the first listed.
NCT00508989 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00508989 about?
NCT00508989 is a clinical study titled "Niacin to Improve Blood Flow in People With Sickle Cell Disease". This study will determine whether niacin can improve blood flow in people with sickle cell disease, in which abnormal red blood cells interfere with blood flow to cause the disease symptoms. Niacin, a drug that has been used to increase HDL (good cholesterol) levels, improves blood flow in people wi...
What is the current status of trial NCT00508989?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2007-07-24. Estimated completion is 2015-12-24.
What interventions are being tested in trial NCT00508989?
The interventions under investigation include: Placebo (DRUG), Acetylcholine (DRUG), L-NMMA (DRUG), Niacin-ER (DRUG).
Who is sponsoring clinical trial NCT00508989?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.