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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes-mellitus
Started May 2010
Shorter than P25 for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJune 9, 2011
June 1, 2011
1 year
April 21, 2010
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination
12-week treatment
Secondary Outcomes (1)
Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination
12-week treatment
Study Arms (2)
Placebo
PLACEBO COMPARATORDehypotin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nang Kuang Pharmaceutical Co., LTD
Tainan, Xinhua Township, 712, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yang Wei Shiung
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 21, 2010
First Posted
April 22, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 9, 2011
Record last verified: 2011-06