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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01108978
Recruitment Status : Terminated
First Posted : April 22, 2010
Last Update Posted : June 9, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Cardiovascular Disease Hypercholesterolemia Drug: Placebo Drug: Dehypotin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study for Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
Study Start Date : May 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination [ Time Frame: 12-week treatment ]

Secondary Outcome Measures :
  1. Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination [ Time Frame: 12-week treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108978


Locations
Taiwan
Nang Kuang Pharmaceutical Co., LTD
Tainan, Xinhua Township, Taiwan, 712
Sponsors and Collaborators
Nang Kuang Pharmaceutical Co., Ltd.
National Taiwan University Hospital
Investigators
Principal Investigator: Yang Wei Shiung National Taiwan University Hospital
More Information

Responsible Party: Hsu Cindy, Nang Kuang Pharmaceutical Co., LTD
ClinicalTrials.gov Identifier: NCT01108978     History of Changes
Other Study ID Numbers: 200911064M
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by Nang Kuang Pharmaceutical Co., Ltd.:
Type 2 Diabetes Mellitus
Cardiovascular Disease
hypercholesterolemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders