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Study of Artery Conditions of 'At-risk' Asian People Not on Lipid-lowering Drugs (CIMT)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00970918
First received: August 25, 2009
Last updated: September 22, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to obtain the distribution of measurements of the intima media thickness of carotid arteries in people with high cardiovascular risk.


Condition Intervention
Cardiovascular Disease
 Procedure: Measurement of the Carotid Intima Media thickness
Biological: Blood sample testing for hs-CRP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Screening
Official Title: Prevalence of Atherosclerotic Disease in Asian Subjects Not on Lipid-lowering Agents, But With at Least Two CVD Risk Factors

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs [ Time Frame: IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid profile of people with high risk of cardiovascular disease but not on lipid lowering drugs [ Time Frame: Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months) ] [ Designated as safety issue: No ]

Enrollment: 2609
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Measurement of the Carotid Intima Media thickness
one time, radiological procedure on both sides of the neck
Biological: Blood sample testing for hs-CRP
one time, blood sample taking

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of signed informed consent.
  • Patients with at least two CVD risk factors but not on lipid-lowering agents

Exclusion Criteria:

  • Subjects with CHD, any conditions that may affect hs-CRP levels.
  • Subjects on any lipid-lowering drug treatment within the last 3 months prior study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970918

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
India
Research Site
Gurgaon, India
Research Site
Jaipur, India
Research Site
Meerut, India
Indonesia
Research Site
Denpasar, Bali, Indonesia
Research Site
Bandung-Jawa, Barat, Indonesia
Research Site
Semarang-Jawa, Tengah, Indonesia
Research Site
Surabaya, Timur, Indonesia
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Malaysia
Research Site
Kuching, Sarawak, Malaysia
Philippines
Research Site
Manila, Philippines
Research Site
Quezon City, Philippines
Taiwan
Research Site
Kaohsiung, Taipei, Taiwan
Research Site
Shilin, Taipei, Taiwan
Research Site
Taoyuan, Taipei, Taiwan
Thailand
Research Site
Patumwan, Bangkok, Thailand
Vietnam
Research Site
Ho Chi Minh City, Ho Chi Min, Vietnam
Research Site
Hanoi, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Guy Yeoman, MD Asia Pacific Regional Office, AstraZeneca Singapore Pte Ltd 8 Wilkie Road, #07-01 Wilkie Edge, Singapore 228095
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00970918     History of Changes
Other Study ID Numbers: D3560L00092
Study First Received: August 25, 2009
Last Updated: September 22, 2010
Health Authority: India: Drugs Controller General of India
Indonesia: Departement Kesehatan (Department of Health)
Indonesia: Komite Etik - Ethical Committee
Indonesia: National Agency of Drug and Food Control
Korea: Institutional Review Board
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Singapore: Health Sciences Authority
Taiwan: Institutional Review Board
Thailand: Ethical Committee
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Cardiovascular disease
Carotid Intima Media Thickness

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013