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

June 7, 2011 updated by: Nang Kuang Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Xinhua Township
      • Tainan, Xinhua Township, Taiwan, 712
        • Nang Kuang Pharmaceutical Co., LTD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
Active Comparator: Dehypotin
Drug: Dehypotin
Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination
Time Frame: 12-week treatment
12-week treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination
Time Frame: 12-week treatment
12-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nang Kuang Pharmaceutical Co., Ltd.

Collaborators

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yang Wei Shiung, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200911064M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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