NCT00247910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

September 19, 2011

Status Verified

September 1, 2011

Enrollment Period

4.7 years

First QC Date

October 31, 2005

Last Update Submit

September 16, 2011

Conditions

Hypertension

Keywords

hypertension, ambulatory BP, office resting BP, hydrochlorothiazide, stress reduction, self-help, psychotherapy, efficacy

Outcome Measures

Primary Outcomes (1)

  • Day time ambulatory BP

    See description

Secondary Outcomes (1)

  • 24 hour ambulatory BP, and office resting BP

    See description

Interventions

HydrochlorothiazideDRUG

Not recorded in detailed description.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Wolfgang Linden, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 2, 2005

Study Start

October 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

September 19, 2011

Record last verified: 2011-09

Locations

CA(1)