Back to resultsEvaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
Primary Purpose
Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypercholesterolemia
Status
Terminated
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
Dehypotin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Cardiovascular Disease, hypercholesterolemia
Eligibility 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
Sites / Locations
- Nang Kuang Pharmaceutical Co., LTD
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Dehypotin
Arm Description
Outcomes
Primary Outcome Measures
Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination
Secondary Outcome Measures
Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination
Full Information
NCT ID
NCT01108978
First Posted
April 21, 2010
Last Updated
June 7, 2011
Sponsor
Nang Kuang Pharmaceutical Co., Ltd.
Collaborators
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01108978
Brief Title
Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nang Kuang Pharmaceutical Co., Ltd.
Collaborators
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypercholesterolemia
Keywords
Type 2 Diabetes Mellitus, Cardiovascular Disease, hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Dehypotin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
Dehypotin
Intervention Description
Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
Primary Outcome Measure Information:
Title
Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination
Time Frame
12-week treatment
Secondary Outcome Measure Information:
Title
Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination
Time Frame
12-week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Wei Shiung
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nang Kuang Pharmaceutical Co., LTD
City
Tainan
State/Province
Xinhua Township
ZIP/Postal Code
712
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
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