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Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker

Information source: Otsuka Beijing Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus; Arteriosclerosis Obliterans

Intervention: Cilostazol (Drug); Probucol (Drug); Cilostazol+Probucol (Drug); Control Group (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Otsuka Beijing Research Institute

Official(s) and/or principal investigator(s):
Xiaohui Guo, M.D., Principal Investigator, Affiliation: No 1 Hospital of Peking University

Summary

1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker 2. To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker

Clinical Details

Official title: A Randomized, Control,Open Label, Multicentre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment.

Detailed description: Efficacy evaluation: Primary efficacy index: After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information Secondary efficacy index: After 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information Safety evaluation: 1. Adverse Event 2. Vital Sign and Physical Examination 3. 12-lead ECG 4. Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)

Eligibility

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 40~75-year-old male or female

- Clarified diagnosis of type 2 diabetes mellitus

- Arteriosclerosis obliterans (ASO) is diagnosed (ASO diagnoses should meet at least

one of the conditions as below:

- ABI<1. 0;

- The pulse of popliteal artery or dorsalis pedis artery is weeken significantly

or is different between left and right sides

- Intermittent claudication, diagnosed as ASO by doctor

- Ultrasonogram showed that there was atherosclerotic plaque in lower limb within

1 year

- Informed Consent Form Signature

Exclusion Criteria:

- Has an allergic history to study drugs

- Use one of the following drugs: other antiplatelet or anticoagulation agents except

Aspirin, other hypolipidemic agents except Statins

- Type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetes

mellitus

- Has severe ASO above Fontaine IIb,

- Hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tract

hemorrhage, etc.)

- Had a myocardial infarction, angina pectoris, or cerebral infarction within the last

3 months

- Congestive heart failure

- Is pregnant, or potentially pregnant, or breastfeeding

- Severe hepatic insufficient or severe renal insufficiency (AST or ALT is 2. 5 times

higher than the upper limit of the normal value range, or serum creatinine is 1. 2 times higher than the upper limit of the normal value range)

- Persistent or hardly controlled hypertension (such as malignant hypertension, BP>

160/100 mmHg)

- Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular

contractions)

- Has a medical history that includes a cardiac syncope or a primary syncope

- Has conditions that may prolong QT interval (such as congenital long QT syndrome,

taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)

- Has severe complications (such as diabetes mellitus ketoacidosis, nonketotic

hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)

- Other conditions that would exclude the subject from this study by doctor's judgement

Locations and Contacts

Peking University First Hospital, Beijing, China
Additional Information

Starting date: October 2008
Last updated: April 21, 2010

Page last updated: August 23, 2015

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