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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

April 21, 2010
June 7, 2011
May 2010
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01108978 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Cardiovascular Disease
  • Hypercholesterolemia
  • Drug: Placebo
    Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
  • Drug: Dehypotin
    Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Dehypotin
    Intervention: Drug: Dehypotin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01108978
200911064M
Yes
Hsu Cindy, Nang Kuang Pharmaceutical Co., LTD
Nang Kuang Pharmaceutical Co., Ltd.
National Taiwan University Hospital
Principal Investigator: Yang Wei Shiung National Taiwan University Hospital
Nang Kuang Pharmaceutical Co., Ltd.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP