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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823849
• Other study ID #: 246-08-802-01
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2009
• Last updated: April 21, 2010
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Otsuka Beijing Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis Obliterans
• Atherosclerosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Cilostazol
From 50mg, Bid, PO after breakfast and dinner. After 1-week of administration, if no significant study drug related discomfort, the dose can increase to 100mg, Bid, PO. Otherwise, remain at the 50 mg level.
• Probucol
250 mg Bid, PO after breakfast and dinner.
• Cilostazol+Probucol
TBD

Other:
• Control Group
Routine treatment

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Beijing Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment.		12 weeks	No