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NCT00279708 · ClinicalTrials.gov registry record · Phase 2
Atorvastatin to Treat Pulmonary Sarcoidosis
A Phase 2 study of Sarcoidosis, Pulmonary, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT00279708 is a Phase 2 study of Sarcoidosis, Pulmonary that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 55 participants, below the 88-participant average among 3 other Sarcoidosis, Pulmonary trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00279708, a Phase 2 study of Sarcoidosis, Pulmonary, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine if atorvastatin (Lipitor) can help patients with pulmonary (lung) sarcoidosis and replace or reduce the need for patients to take steroids, such as prednisone. Sarcoidosis is an inflammatory disease that can affect nearly any part of the body. Pulmonary sarcoidosis may resolve on its own or it may progress to irreversible lung damage, disability, and death. Many sarcoidosis patients are treated with prednisone, but the drug is not effective in all patients, and it can cause serious side effects, such as high blood pressure, sugar diabetes, eye cataracts, and bone thinning. Patients with stage II or III pulmonary sarcoidosis between 18 and 70 years of age who require prednisone may be eligible for this study. Candidates are screened with the tests and procedures described below. Participants are randomly assigned to one of two treatment groups: one group takes atorvastatin; the other takes a placebo (a look-alike pill that has no active ingredient to fight sarcoidosis). Both groups take the pills by mouth once a day for 12 months. When treatment begins, participants begin to have their prednisone dosage tapered (reduced). The tapering is done over 8 weeks until the dose is reduced by 90 percent. Patients are evaluated periodically to determine if the two groups differ in how long they can remain on the reduced dose of prednisone without having their symptoms recur, requiring an increase in the prednisone dose. A full battery of tests is done at the initial screening visit and at the 26- and 52-week follow-up visits, requiring hospitalization for 3-5 days. Additional interim outpatient assessments are done at 6, 12, 18 and 36 weeks. The full battery of tests at the initial screening and the 26- and 52-week visits includes the following: * Medical history, physical examination, blood and urine tests, assessment of disease severity and activity. * Questionnaires. * Chest x-ray (CXR) and computed tomography (CT) scan. * Abdominal ultrasound.
Conditions Studied
Interventions
- DRUG Atorvastatin
- OTHER Placebo Oral Tablet
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2006-01 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00279708
The ClinicalTrials.gov registry entry for NCT00279708 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 3 other Sarcoidosis, Pulmonary trials with a reported enrollment target (37% 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 1 condition, with Sarcoidosis, Pulmonary appearing as the primary indexed condition, and to 2 interventions - of which Atorvastatin is the first listed.
NCT00279708 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00279708 about?
NCT00279708 is a clinical study titled "Atorvastatin to Treat Pulmonary Sarcoidosis". This study will determine if atorvastatin (Lipitor) can help patients with pulmonary (lung) sarcoidosis and replace or reduce the need for patients to take steroids, such as prednisone. Sarcoidosis is an inflammatory disease that can affect nearly any part of the body. Pulmonary sarcoidosis may reso...
What is the current status of trial NCT00279708?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2006-01. Estimated completion is 2015-12.
What conditions does trial NCT00279708 study?
This clinical trial studies the following conditions: Sarcoidosis, Pulmonary.
What interventions are being tested in trial NCT00279708?
The interventions under investigation include: Atorvastatin (DRUG), Placebo Oral Tablet (OTHER).
Who is sponsoring clinical trial NCT00279708?
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 NCT00279708 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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