Trial · NCT00279708

Atorvastatin to Treat Pulmonary Sarcoidosis

NCT00279708, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2016-08-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Atorvastatin to Treat Pulmonary Sarcoidosis. Trials, record NCT00279708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00279708

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Atorvastatin to Treat Pulmonary Sarcoidosis
NCT number: NCT00279708
Status: Completed
Phases: Phase 2
Enrollment: 55 participants, actual
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Conditions: Sarcoidosis, Pulmonary
Interventions: Atorvastatin, Placebo Oral Tablet
First posted: 2006-01-19
Last updated: 2017-05-22
Results first posted: 2016-08-12
Limitations and caveats: The recruitment goal of 96 subjects was not met due to slow accrual. The primary endpoint analysis was based on the available subject data.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Steroid Sparing Period	1 year	The duration of steroid sparing was defined as the date when the target dose of prednisone was reached until the date at which the dose was increased and/or met the relapse (flare) criteria; or until the 12 month study phase ended if no prednisone dose increase was required. The steroid sparing period was measured in units of days. The prednisone target dose was defined as a 90% reduction of the baseline dose or an absolute prednisone dose of 4 mg/day or less.
Secondary	Pulmonary Sarcoidosis Flares	1 year	Flare rates and relative risk: Flares (relapses) were defined as the physiological deterioration in pulmonary function due to worsened pulmonary inflammation. The criteria used for a pulmonary flare included: \> 15% decline in static function (FEV1 post, FVC post); or (\> 20% DLCO adj); or a \> 15% decline in walk distance as measured by the six minute walk test, or via a decline in oxygen consumption collected during a cardiopulmonary exercise test (CPET). Additional factors considered included an increase in dyspnea (\>15% increase in the dyspnea scale (TDI); and/or significant radiographic worsening. Clinical assessment of the patient's status may have been factored into the criteria for flare determination as well.
Secondary	Pulmonary Function Tests	12 month treatment period	Spirometry measurements (FVC and FEV1) obtained post-bronchodilator Diffusion, adjusted for hemoglobin
Secondary	Exercise Performance	12 month treatment period	Cardiopulmonary Exercise Tests (VO2 peak, VO2/work, VECO2) Six minute Walk Test (distance, Borg scale)
Secondary	Quality of Life and Dyspnea Scales	12 month treatment period	St. George's Respiratory Questionnaire SF-36 Modified MRC Dyspnea Scale
Other	Chest Imaging	12 month treatment period	HRCT Chest radiographs

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	The Steroid Sparing Period	1 year	days	MEAN
SECONDARY	Pulmonary Sarcoidosis Flares	1 year
SECONDARY	Pulmonary Function Tests	12 month treatment period
SECONDARY	Exercise Performance	12 month treatment period
SECONDARY	Quality of Life and Dyspnea Scales	12 month treatment period
OTHER_PRE_SPECIFIED	Chest Imaging	12 month treatment period

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Steroid Sparing Period	Intervention Group (Atorvastatin)		301	Inter-Quartile Range 2 to 315	days
The Steroid Sparing Period	Control Group (Placebo)		257	Inter-Quartile Range 152 to 322	days

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intervention Group (Atorvastatin)	27
Overall Study	STARTED	Control Group (Placebo)	28
Overall Study	COMPLETED	Intervention Group (Atorvastatin)	24
Overall Study	COMPLETED	Control Group (Placebo)	24
Overall Study	NOT COMPLETED	Intervention Group (Atorvastatin)	3
Overall Study	NOT COMPLETED	Control Group (Placebo)	4

Source ClinicalTrials.gov

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Aldolase Increase	Investigations	Intervention Group (Atorvastatin)	2	27	2
other	Aldolase Increase	Investigations	Control Group (Placebo)	3	28	3
other	ACE Level increased	Investigations	Intervention Group (Atorvastatin)	2	27	2
other	ACE Level increased	Investigations	Control Group (Placebo)	1	28	1
other	Alkaline Phosphatase Increase	Investigations	Intervention Group (Atorvastatin)	3	27	3
other	Alkaline Phosphatase Increase	Investigations	Control Group (Placebo)	1	28	1
other	Alanine aminotransferase Increased	Investigations	Intervention Group (Atorvastatin)	13	27	13
other	Alanine aminotransferase Increased	Investigations	Control Group (Placebo)	4	28	4
other	Asparatate aminotransferase Increased	Investigations	Intervention Group (Atorvastatin)	14	27	14
other	Asparatate aminotransferase Increased	Investigations	Control Group (Placebo)	5	28	5

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention Group (Atorvastatin)
Total, all-cause mortality	Control Group (Placebo)
Total, other adverse events	Intervention Group (Atorvastatin)	16	27
Total, other adverse events	Control Group (Placebo)	12	28
Total, serious adverse events	Intervention Group (Atorvastatin)	12	27
Total, serious adverse events	Control Group (Placebo)	16	28

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
9110911	BACKGROUND	PubMed
10430755	BACKGROUND	PubMed
12824213	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Intervention Group (Atorvastatin) vs Control Group (Placebo): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00279708

GET https://conductscience.org/api/trials/v1/NCT00279708/events?page=2

API reference For AI assistants