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

NCT00823849 | Completed Phase 4

• 1 other identifier: 246-08-802-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Arteriosclerosis Obliterans

Keywords

type 2 diabetes mellitus, with Arteriosclerosis obliterans

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

1

EXPERIMENTAL

Drug: Cilostazol

2

EXPERIMENTAL

Drug: Probucol

3

EXPERIMENTAL

Drug: Cilostazol+Probucol

4

OTHER

Control Group, regular treatment

Other: Control Group

Interventions

Cilostazol DRUG

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.

Also known as: pletaal

1

Probucol DRUG

250 mg Bid, PO after breakfast and dinner.

Also known as: Changtai

2

Cilostazol+Probucol DRUG

Also known as: Pletaal and Changtai

3

Control Group OTHER

Routine treatment

Also known as: Routine treatment

4

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Arteriosclerosis Obliterans

Interventions

Cilostazol; Probucol; Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xiaohui Guo, M.D.

  No 1 Hospital of Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: October 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2010
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

CN (1)