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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014