Simvastatin Therapy for Moderate and Severe COPD (NCT01061671) | Clinical Trial Compass
TerminatedPhase 3
Simvastatin Therapy for Moderate and Severe COPD
Stopped: Futility
United States885 participantsStarted 2010-03
Plain-language summary
To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male and female subjects, 40-80 years of age.
✓. Clinical diagnosis of at least moderate COPD as defined by the GOLD criteria:
✓. Postbronchodilator FEV1(forced expiratory volume at one second)/FVC(forced vital capacity) \< 70%,
✓. Postbronchodilator FEV1 (forced expiratory volume at one second) \< 80% predicted, with or without chronic symptoms (i.e., cough, sputum production).
✓. Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.
✓. Must meet one or more of the following 4 conditions
✓. Be using supplemental oxygenate
✓. Receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year,
Exclusion criteria
✕. Patients who:
✕. are on statin drugs.
✕. should be on statins based on established risk stratification using the ATP-III (Adult Treatment Panel) to determine 10 year risk.
✕. Documented history of active coronary heart disease, such as unstable angina, prior myocardial infarction, stroke, symptomatic peripheral vascular or carotid artery disease, or congestive heart failure within the past 3 months.
✕. The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy \< 3 years.
✕. Special patient groups: prisoners, pregnant women, institutionalized patients
✕. Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study.