Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease

Phase 4

Terminated

• Conditions: Cardiovascular Disease; Hypercholesterolemia; Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: 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

Study Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Study Start: 2010-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-09

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