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

This study has been terminated.
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by:
Nang Kuang Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01108978
First received: April 21, 2010
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Cardiovascular Disease
Hypercholesterolemia
 Drug: Placebo
Drug: Dehypotin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nang Kuang Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination [ Time Frame: 12-week treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination [ Time Frame: 12-week treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hsu Cindy, Nang Kuang Pharmaceutical Co., LTD
ClinicalTrials.gov Identifier: NCT01108978     History of Changes
Other Study ID Numbers: 200911064M
Study First Received: April 21, 2010
Last Updated: June 7, 2011
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013