NCT00640549TerminatedPhase 4
Impact of Atorvastatin on the Distribution, Composition, and Metabolism of LDL and HDL Subfractions: A Double-blind Placebo-controlled Phase IV Study With Patients Suffering From Combined Hyperlipidemia and Diabetes. Atorvastatin and LDL Profile in NIDDM (ALPIN Study)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country41 target enrollmentStarted: March 2003Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
Study Overview
Brief Summary
The study will investigate the effects of atorvastatin on the concentrations of small, dense LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these effects.
Detailed Description
This study was terminated on October 6, 2004. The study terminated prematurely because of a higher screening failure rate than expected. There were no safety or efficacy reasons involved in the decision to terminate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female subjects with a diagnosis of type 2 diabetes mellitus who either have never had a major adverse cardiac event (MACE) diagnosed before or who had a MACE diagnosed at least 6 months ago, but who, according to the judgement of the treating general practitioner, do not receive any hyperlipidemic therapy. Major adverse cardiac events (MACE) include myocardial infarction, coronary angioplasty, coronary artery bypass graft or other revascularization procedures.
- •At Screening:
- •Visit 1 (week -4):
- •Male patients aged >35 and ≤75 years and postmenopausal female patients ≤75 years with a diagnosis of type 2 diabetes mellitus
- •Patients have been euthyroid for at least six months
- •Written informed consent obtained
- •At Visit 2 (week 0):
- •LDL cholesterol ≥130 mg/dl (3.3 mmol/l ) and <190 mg/dl (4.9 mmol/l)
- •Triglycerides <150 mg/dl (1.69 mmol/l ) and <600 mg/dl (11.3 mmol/l)
- •Sum of LDL-5 and LDL-6 cholesterol ≥25 mg/dl (0.65 mmol/l)
- •Follicle stimulating Hormone (FSH) >30 U/l in female patients aged <60 years or FSH >20 U/l in female patients aged ≥60 years
Exclusion Criteria
- •HbA1c > 8.0
- •Creatine kinase (CK) >5 times the upper limit of normal
- •Patients having taken lipid lowering medication within 8 weeks of the screening visit
Arms & Interventions
2
Placebo Comparator
Intervention: Placebo (Drug)
1
Active Comparator
Intervention: Atorvastatin (Drug)
Outcomes
Primary Outcomes
Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
Time Frame: 8 weeks (visit 4)
Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)
Time Frame: 8 weeks (visit 4)
Secondary Outcomes
- Changes in concentration of apolipoprotein B in VLDL, IDL, LDL-1 through LDL-6 and apolipoprotein A I in HDL subfractions 2a, 2b, and HDL-3 compared with screening (visit 1)(8 weeks (visit 4))
- Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)(8 weeks (visit 4))
- Changes in size of LDL subfractions compared with screening (visit 1)(8 weeks (visit 4))
- Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)(8 weeks (visit 4))
Investigators
Study Sites (1)
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