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NCT00072826 · ClinicalTrials.gov registry record · Phase 1
Atorvastatin Therapy to Improve Endothelial Function in Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT00072826: Completed Phase 1 study of Sickle Cell Disease, sponsored by National Institutes of Health Clinical Center (CC).
NCT00072826 is a Phase 1 study of Sickle Cell Disease that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 44 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00072826, a Phase 1 study of Sickle Cell Disease, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the effects of oral atorvastatin on the linings of blood vessels in patients with sickle cell disease, plus the agent's effect on blood markers of inflammation and blood vessel function. Sickle cell disease is a recessive genetic disorder and the most common genetic disease affecting African Americans. Inherited are abnormal genes that make hemoglobin, the substance within red blood cells that carries oxygen from the lungs to the body. In the disease, sickle hemoglobin leads to rigidity or hardness of the red cells, causing obstruction in small blood vessels, inflammation, and injury to organs when the flow of blood to them is blocked. Some medications already prescribed for other diseases, such as atorvastatin, which is used for lowering cholesterol levels, can improve blood flow. Patients 18 to 65 years of age who have sickle cell disease, who have not had an acute pain episode within the previous week, and who are not pregnant or lactating may be eligible for this study. They will undergo a complete medical history; physical examination; baseline blood tests; and echocardiogram, in which an ultrasound wand is placed against the chest wall to get images inside the heart and blood vessels. In addition, patients will have blood flow studies. During the procedure, they will lie in an adjustable reclining chair for 5 to 6 hours. There will be 20- to 30-minute rests between specific activities and blood samples will be drawn intermittently for testing. Small tubes will be placed in the artery of the forearm at the inside of the elbow. Normal saline will be infused into one tube. A small pressure cuff will be applied to the wrist and a larger cuff to the upper arm. Both cuffs will be attached to an inflation device. A device like a rubber band, a strain gauge, will be placed around the widest part of the forearm. When the pressure cuffs are inflated, blood will flow into the arm, stretching the gauge proportion to blood flow, and information wi
Conditions Studied
Interventions
- DRUG Acetylcholine
- DRUG L-NMMA
- DRUG Oxypurinol
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2003-11-04 |
| Est. Completion | 2007-08-24 |
| Phase | Phase 1 |
What the finished NCT00072826 record still lists
NCT00072826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 3 interventions - of which Acetylcholine is the first listed.
NCT00072826 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00072826 about?
NCT00072826 is a clinical study titled "Atorvastatin Therapy to Improve Endothelial Function in Sickle Cell Disease". This study will examine the effects of oral atorvastatin on the linings of blood vessels in patients with sickle cell disease, plus the agent's effect on blood markers of inflammation and blood vessel function. Sickle cell disease is a recessive genetic disorder and the most common genetic disease a...
What is the current status of trial NCT00072826?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2003-11-04. Estimated completion is 2007-08-24.
What conditions does trial NCT00072826 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT00072826?
The interventions under investigation include: Acetylcholine (DRUG), L-NMMA (DRUG), Oxypurinol (DRUG).
Who is sponsoring clinical trial NCT00072826?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00072826 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00072826's enrollment target sits among peer trials
44 120th of 213 higher than 94 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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