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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.
ClinicalTrials.gov Identifier:
First Posted: January 11, 2011
Last Update Posted: September 11, 2013
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.
Information provided by (Responsible Party):
The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.

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:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Compliance rate [ Time Frame: 6 months ]
    Identify the percentage of subjects compliant to their antihypertensive treatment.

Secondary Outcome Measures:
  • Health Related Quality of Life (MINICHAL Score) [ Time Frame: 6 months ]
    To compare and identify changes in the quality of life before and after anti-hypertensive treatment.

  • Type of pharmacological treatments [ Time Frame: 6 months ]
    To identify the pharmacological treatments used by physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.

  • Factors affecting adherence to treatment [ Time Frame: 6 months ]
    To identify associated factors that may alter adherence to anti-hypertensive treatment.

  • Compliance rate by antihypertensive regimen used [ Time Frame: 6 months ]
    To compare treatment rate for different antihypertensive regimen used

  • Percentage of controlled patients [ Time Frame: 6 months ]
    To identify the percentage of patients reaching their target blood pressure according to the JNCVII criteria.

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
multi-centre survey of patients

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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01274494     History of Changes
Other Study ID Numbers: NIS-CME-ATA-2010/1
First Submitted: January 10, 2011
First Posted: January 11, 2011
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents