Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
Phase 4
Terminated
- Conditions
- Cardiovascular DiseaseHypercholesterolemiaType 2 Diabetes Mellitus
- Interventions
- Drug: PlaceboDrug: Dehypotin
- Registration Number
- NCT01108978
- Lead Sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the Efficacy and Safety of Dehypotin® in the Patients with Type 2 Diabetes Mellitus or Cardiovascular Disease. Eligible patients will be randomly assigned to 1 of 2 arms, either Dehypotin® or placebo, and will receive the diet advisement throughout the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Male or female
- 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
- Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Dehypotin Dehypotin -
- Primary Outcome Measures
Name Time Method Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination 12-week treatment
- Secondary Outcome Measures
Name Time Method Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination 12-week treatment
Trial Locations
- Locations (1)
Nang Kuang Pharmaceutical Co., LTD
🇨🇳Tainan, Xinhua Township, Taiwan
Nang Kuang Pharmaceutical Co., LTD🇨🇳Tainan, Xinhua Township, Taiwan