- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247910
Behavioural Treatment of Hypertension
September 16, 2011 updated by: University of British Columbia
The objective of the study is to determine whether psychological therapy (self-help or individualized intense stress management) is different than a single drug treatment in terms of their effectiveness for lowering blood pressure.
Study Overview
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2B5
- UBC Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must be at least 19 years of age
- subjects can be male or female
- subjects must have an average resting blood pressure of >140 systolic pressure an/ or >90 diastolic pressure off anti-hypertensive medication
Exclusion Criteria:
- must not be on more than 2 blood pressure lowering drugs
- must not have known or suspected of having secondary hypertension on initial examination
- must not be pregnant or anticipating pregnancy during study period
- must not have history of allergy, hypersensitivity or intolerance to diuretics
- must not have medical condition that may result in an unacceptable risk of complications due to uncontrolled hypertension during time period of study
- must not have average resting BP readings that exceed 190 systolic, or 115 diastolic, or have two consecutive readings of 180 systolic or 110 diastolic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Day time ambulatory BP
Time Frame: See description
|
See description
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
24 hour ambulatory BP, and office resting BP
Time Frame: See description
|
See description
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wolfgang Linden, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
October 31, 2005
First Submitted That Met QC Criteria
November 1, 2005
First Posted (Estimate)
November 2, 2005
Study Record Updates
Last Update Posted (Estimate)
September 19, 2011
Last Update Submitted That Met QC Criteria
September 16, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C01-0175
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.