Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00072826
The ClinicalTrials.gov registry entry for NCT00072826 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (85% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Sickle Cell Disease
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.
-
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
RECRUITING · Phase 1
-
Hematopoietic Stem Cell BCL11A Enhancer Gene Editing for Severe β-Hemoglobinopathies
RECRUITING · Phase 1
-
Gene Correction in Autologous CD34+ Hematopoietic Stem Cells (HbS to HbA) to Treat Severe Sickle Cell Disease
RECRUITING · Phase 1
-
PET Imaging of Vaso-Occlusive Crisis (VOC) in SCD
RECRUITING · Phase 1
-
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
RECRUITING · Phase 1
-
Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
RECRUITING · Phase 1
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.