Behavioural Treatment of Hypertension | NCT00247910

Studies
Behavioural Treatment of Hypertension

NCT00247910

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Sep 19, 2011Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Hydrochlorothiazide

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Oct 31, 2005

First Submission Date that Met QC Criteria

Nov 1, 2005

First Posted Date

Nov 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2011

Last Update Posted Date

Sep 19, 2011Estimated

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Name	Type	Description	Arm Group Labels	Other Names
Hydrochlorothiazide	Drug	Not recorded in detailed description.

Measure	Description	Time Frame
Day time ambulatory BP		See description

Measure	Description	Time Frame
24 hour ambulatory BP, and office resting BP		See description

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolfgang Linden, PhD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UBC Hospital		Vancouver	British Columbia	V6T 2B5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006852	Hydrochlorothiazide

Ancestor Terms

ID	Term
D002740	Chlorothiazide
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones

Browse Leaves

Not provided

Browse Branches

Not provided