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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:
NCT00823849
First received: January 14, 2009
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
  Purpose
  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

Condition Intervention Phase
Type 2 Diabetes Mellitus
Arteriosclerosis Obliterans
 Drug: Cilostazol
Drug: Probucol
Drug: Cilostazol+Probucol
Other: Control Group
 Phase 4

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

Resource links provided by NLM:

Drug Information available for: Cilostazol
U.S. FDA Resources

Further study details as provided by Otsuka Beijing Research Institute:

Primary Outcome Measures:
  • Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Other Name: pletaal
Experimental: 2 Drug: Probucol
250 mg Bid, PO after breakfast and dinner.
Other Name: Changtai
Experimental: 3 Drug: Cilostazol+Probucol
TBD
Other Name: Pletaal and Changtai
No Intervention: 4
Control Group
 Other: Control Group
Routine treatment
Other Name: Routine 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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823849

Locations
China
Peking University First Hospital
Beijing, China
Sponsors and Collaborators
Otsuka Beijing Research Institute
Investigators
Principal Investigator: Xiaohui Guo, M.D. No 1 Hospital of Peking University
  More Information

No publications provided

Responsible Party: Quanjie Wei, Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT00823849     History of Changes
Other Study ID Numbers: 246-08-802-01
Study First Received: January 14, 2009
Last Updated: April 21, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Otsuka Beijing Research Institute:
type 2 diabetes mellitus, with Arteriosclerosis obliterans

Additional relevant MeSH terms:
Arteriosclerosis
Arteriosclerosis Obliterans
Atherosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Probucol
Cilostazol
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Antioxidants
Protective Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 16, 2013