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An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00681759
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : October 31, 2008
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date May 20, 2008
First Posted Date May 21, 2008
Last Update Posted Date October 31, 2008
Study Start Date January 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: May 20, 2008)
Cross-sectional survey, SitePro Survey Domains including; background, UGI screening, PPI and H2 blocker usage, interaction between UGI and LDA ,UGI symptoms, HADS, Morisky Medication Taking Behavior Scale, SF12, SSA-P [ Time Frame: Once at enrollment ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00681759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 20, 2008)
EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization [ Time Frame: Four times daily for three months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
Official Title A Prospective Descriptive, Multi-National, Multi-Centre Observational Study of Burden of Upper GI-Symptoms in Subjects With Cardiovascular Risk or Disease Receiving Treatment With Low-Dose Aspirin
Brief Summary The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with cardiovascular risk or disease receiving LDA treatment in specialist and primary care clinics.
Condition Cardiovascular Disease
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Patients who have been prescribed Low Dose Aspirin (LDA) usage in the past 12 months, or those about to begin LDA, will complete a one-time in-office survey using an electronic personal digital assistant (PDA) device (termed SitePro).
  • 2
    420 subjects stratified into three groups varying on length of time using Low Dose Aspirin (LDA)
  • 3
    Up to 20 subjects from the three EMA groups will be interviewed to further debrief their experience with Low Dose Aspirin (LDA) and upper GI symptoms.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 30, 2008)
1836
Original Estimated Enrollment
 (submitted: May 20, 2008)
2000
Actual Study Completion Date September 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Provision of signed written inform consent.
  • Physician prescribed or recommended daily intake of Low Dose Aspirin (LDA) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months.
  • Established cardiovascular disease, such as CAD (CoronaryArtery Disease), previous TIA (Transient Ischemic Attack), ischemic stroke or subjects with known risk factors for cardiovascular disease without having experienced cardiovascular events

Exclusion Criteria:

  • Need for concomitant treatment with a non-ASA NSAID (Nonsteroidal Antiinflammatory Drugs) including acyclooxygenase-2 (COX-2) selective NSAID. Occasional use of up to 1 day/week is allowed.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00681759
Other Study ID Numbers D961FC00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tore Lind, MD, Medical Science Director, Nexium, AstraZeneca Pharmaceuticals
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date October 2008