Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
NCT ID: NCT01108978
Last Updated: 2011-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
60 participants
INTERVENTIONAL
2010-05-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
Dehypotin
Dehypotin
Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
Interventions
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Placebo
Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
Dehypotin
Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
Eligibility Criteria
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Inclusion Criteria
* Age 20-75 years
* Diagnosis of type II Diabetes Mellitus for at least 3 months and/or clinical evident cardiovascular disease (CVD)
* A hemoglobin A1c concentration has to be \< 8% before screening
Exclusion Criteria
* Known hypersensitivity to Pravastatin or any of its components
* Have a history of homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia
* Significant medical illness
* Known serious conditions, e.g. serum creatine kinase(CK)levels 2.5 times upper limit of normal
* Subjects being treated with drugs influence serum lipid concentrations
* Subjects who have cancer or been receiving the cancer chemotherapy
20 Years
75 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Nang Kuang Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Nang Kuang Pharmaceutical Co., LTD
Principal Investigators
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Yang Wei Shiung
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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Nang Kuang Pharmaceutical Co., LTD
Tainan City, Xinhua Township, Taiwan
Countries
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Other Identifiers
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200911064M
Identifier Type: -
Identifier Source: org_study_id
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