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

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nang Kuang Pharmaceutical Co., Ltd.
• Collaborator: National Taiwan University Hospital

Criteria

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