Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker - Full Text View

Sponsor:	Otsuka Beijing Research Institute
Information provided by:	Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:	NCT00823849

Purpose

To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Probucol 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
Estimated Study Completion Date:	March 2010
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Experimental	Drug: Probucol 250 mg Bid, PO after breakfast and dinner.
3: Experimental	Drug: Cilostazol+Probucol TBD
4: No Intervention Control Group	Other: Control Group 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:

Adverse Event
Vital Sign and Physical Examination
12-lead ECG
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:	Otsuka Beijing Research Institute ( Quanjie Wei )
Study ID Numbers:	246-08-802-01
Study First Received:	January 14, 2009
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00823849 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Otsuka Beijing Research Institute:

type 2 diabetes mellitus, with Arteriosclerosis obliterans

Additional relevant MeSH terms:

Atherosclerosis
Antimetabolites
Respiratory System Agents
Vasodilator Agents
Arteriosclerosis Obliterans
Antioxidants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Arteriosclerosis
Neuroprotective Agents
Fibrin Modulating Agents
Therapeutic Uses
Cardiovascular Diseases

Arterial Occlusive Diseases
Cilostazol
Probucol
Metabolic Diseases
Antilipemic Agents
Vascular Diseases
Diabetes Mellitus
Anti-Asthmatic Agents
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Anticholesteremic Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010