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Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

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NCT00640549

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bad Muenster Am Stein, , 55583 Germany
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hyperlipidemia, Type 2 Diabetes Mellitus, Non-Insulin Dependent Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

5. Triglycerides

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 >20 U/l in female patients aged ≥60 years

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00640549
Pfizer
Terminated
Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

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Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
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)
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hyperlipidemia
  • Diabetes Mellitus, Type 2
  • Non-Insulin Dependent Diabetes Mellitus
  • Drug: Atorvastatin
    After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the atorvastatin group were treated with atorvastatin 20 mg tablets administered once daily orally for 8 weeks.
    Other Name: Lipitor, Sortis
  • Drug: Placebo
    After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the placebo group were treated with placebo 20 mg tablets administered once daily orally for 8 weeks.
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Active Comparator: 1
    Intervention: Drug: Atorvastatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
October 2004
Not Provided

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):

  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

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
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00640549
A2581040
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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