Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST) (ACTFAST)
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| ClinicalTrials.gov Identifier: NCT00442845 |
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Recruitment Status :
Completed
First Posted : March 2, 2007
Last Update Posted : February 18, 2021
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Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
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Brief Summary:
Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Arteriosclerosis Diabetes Mellitus, Type 2 Cerebrovascular Accident Dyslipidemia Peripheral Vascular Disease | Drug: Atorvastatin (Lipitor) | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 2080 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | ACTFAST: Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration. A Multicenter, Twelve-Week Treatment, Single Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving Low Density Lipoprotein Cholesterol (LDL-C) Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg |
| Study Start Date : | January 2003 |
| Actual Primary Completion Date : | February 2004 |
| Actual Study Completion Date : | February 2004 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
Secondary Outcome Measures :
- Percentage of subjects achieving:
- LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
- Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
- Either the LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
- Both the LDL-C <100mg/dL (<2.6 mmol/L) and TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
- LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment by LDL-C strata.
- LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
- The mean percent change in LDL-C, high density lipoprotein cholesterol (HDL-C),TC/HDL-C ratio, non HDL-C (in subjects with triglycerides [TG] ≥200 mg/dL or 2.3 mmol/L), TC and TG from baseline to 6 and 12 weeks of treatment.
- Change from baseline in apolipoprotein-B (Apo-B) and change from baseline in glycosylated hemoglobin (HbA1c) was assessed at 12 weeks.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.
- Triglycerides up to 600 mg/dL.
- History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events
Exclusion Criteria:
- Pregnancy or lactation, use of high statin doses (>40mg) at baseline, liver or renal problems, use of other drugs that would interfere with evaluation of efficacy or cause safety problems, uncontrolled hypertension, diabetes or hypothyroidism, recent cardiac event of procedure, high baseline CPK levels
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442845
Locations
Show 120 study locations
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| ClinicalTrials.gov Identifier: | NCT00442845 |
| Other Study ID Numbers: |
A2581087 |
| First Posted: | March 2, 2007 Key Record Dates |
| Last Update Posted: | February 18, 2021 |
| Last Verified: | February 2021 |
Additional relevant MeSH terms:
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Stroke Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Diabetes Mellitus, Type 2 Dyslipidemias Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Lipid Metabolism Disorders Cardiovascular Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Atherosclerosis Arterial Occlusive Diseases Coronary Disease Heart Diseases Atorvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |