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COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01274494
First received: January 10, 2011
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a multi-centre survey of patients who are currently using lipid-lowering pharmacological treatment for at least 3 months and with no dose change for a minimum of 6 weeks in Jordan and Lebanon


Condition
High Blood Pressure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Identify the number and percentage of subjects adequately controlling their high blood pressure according to the JNC VII criteria. [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    Identify the number and percentage of subjects adequately controlling their high blood pressure according to the JNC VII criteria.

  • Identify the number and percentage of subjects adequately controlling their high blood pressure according to the JNC VII criteria. [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
    Identify the number and percentage of subjects adequately controlling their high blood pressure according to the JNC VII criteria.

  • Identify the number and percentage of subjects adequately controlling their high blood pressure according to the JNC VII criteria. [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
    Identify the number and percentage of subjects adequately controlling their high blood pressure according to the JNC VII criteria.


Secondary Outcome Measures:
  • To compare and identify changes in the quality of life before and after anti-hypertensive treatment. [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    To compare and identify changes in the quality of life before and after anti-hypertensive treatment.

  • To compare and identify changes in the quality of life before and after anti-hypertensive treatment. [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
    To compare and identify changes in the quality of life before and after anti-hypertensive treatment.

  • To compare and identify changes in the quality of life before and after anti-hypertensive treatment. [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
    To compare and identify changes in the quality of life before and after anti-hypertensive treatment.

  • To identify the pharmacological treatments and practice used my physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension. [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    To identify the pharmacological treatments and practice used my physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.

  • To identify the pharmacological treatments and practice used my physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension. [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
    To identify the pharmacological treatments and practice used my physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.

  • To identify the pharmacological treatments and practice used my physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension. [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
    To identify the pharmacological treatments and practice used my physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.


Enrollment: 1501
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

multi-centre survey of patients

Criteria

Inclusion Criteria:

  • Patients older than 21 years of age
  • Patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the Joint National Committee VII)
  • Patients capable of providing an informed consent

Exclusion Criteria:

  • Patients with secondary hypertension
  • Pregnant women or nursing mothers
  • Patients with acute illnesses or psychiatric diagnosis
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01274494     History of Changes
Other Study ID Numbers: NIS-CME-ATA-2010/1
Study First Received: January 10, 2011
Last Updated: March 20, 2013
Health Authority: Jordan: Ethical Committee
Lebanon: Institutional Review Board

Keywords provided by AstraZeneca:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013