Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
NCT00640549
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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):
1. Male patients aged >35 and ≤75 years and postmenopausal female patients ≤75 years with a diagnosis of type 2 diabetes mellitus
2. Patients have been euthyroid for at least six months
3. Written informed consent obtained
At Visit 2 (week 0):
4. LDL cholesterol ≥130 mg/dl (3.3 mmol/l ) and <190 mg/dl (4.9 mmol/l)
5. Triglycerides <150 mg/dl (1.69 mmol/l ) and <600 mg/dl (11.3 mmol/l)
6. Sum of LDL-5 and LDL-6 cholesterol ≥25 mg/dl (0.65 mmol/l)
7. Follicle stimulating Hormone (FSH) >30 U/l in female patients aged <60 years or FSH >20 U/l in female patients aged ≥60 years
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus | |||
Official Title ICMJE | 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) | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 41 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
At Screening: Visit 1 (week -4):
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 35 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00640549 | |||
Other Study ID Numbers ICMJE | A2581040 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |