Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

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NCT00640549

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Study Location
Pfizer Investigational Site
Bad Muenster Am Stein, , 55583, Germany
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

By email

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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 <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
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

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Hyperlipidemia, Type 2 Diabetes Mellitus, Non-Insulin Dependent Diabetes MellitusAtorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
NCT00640549
  1. Bad Muenster Am Stein,
  2. Bosenheim,
  3. Bretten,
  4. Dresden,
  5. Duisburg,
  6. Essen,
  7. Goch,
  8. Heidelberg,
  9. Kuenzing,
  10. Offenbach,
  11. Offenbach,
  12. Offenbach,
  13. Rain,
  14. Schwabenheim,
ALL GENDERS
35 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Hyperlipidemia
  • Diabetes Mellitus, Type 2
  • Non-Insulin Dependent Diabetes Mellitus
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Active Comparator: 1
    Intervention: Drug: Atorvastatin
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
 (submitted: March 20, 2008)		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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