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

NCT ID: NCT01108978

Last Updated: 2011-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Cardiovascular Disease Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks

Dehypotin

Group Type ACTIVE_COMPARATOR

Dehypotin

Intervention Type DRUG

Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks

Interventions

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Placebo

Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks

Intervention Type DRUG

Dehypotin

Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role collaborator

Nang Kuang Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Nang Kuang Pharmaceutical Co., LTD

Principal Investigators

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Yang Wei Shiung

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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Nang Kuang Pharmaceutical Co., LTD

Tainan City, Xinhua Township, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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200911064M

Identifier Type: -

Identifier Source: org_study_id

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