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Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bad Muenster Am Stein, , 55583 Germany
Contact
1-800-718-1021
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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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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