Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors

NCT00407537

Last updated date
Study Location
Pfizer Investigational Site
Desamparados, San Jose, , Costa Rica
Contact
1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension, Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-79 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects currently receiving a statin or stopped statin within 6 months prior to
enrollment.


- Subjects with a history of myocardial infarction and subjects with coronary bypass
graft or intra-coronary interventions.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
Official Title  ICMJE A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice
Brief Summary To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Hypercholesterolemia
Intervention  ICMJE Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
Study Arms  ICMJE Experimental: Caduet
Open label caduet added to usual care regimen followed by investigators.
Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2009)
1531
Original Enrollment  ICMJE
 (submitted: December 4, 2006)
1968
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion Criteria:

  • Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
  • Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 35 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Costa Rica,   Croatia,   Czech Republic,   Dominican Republic,   Indonesia,   Jordan,   Korea, Republic of,   Kuwait,   Lebanon,   Malaysia,   Mexico,   Panama,   Philippines,   Russian Federation,   Saudi Arabia,   Taiwan,   Thailand,   Turkey,   United Arab Emirates,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407537
Other Study ID Numbers  ICMJE A3841047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP