NCT00129909

Brief Summary

The objective of this study is to assess whether the implementation of a primary treatment algorithm using a fixed dose combination therapy will improve the management of hypertension when compared to usual management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,081

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

August 10, 2005

Last Update Submit

June 13, 2012

Conditions

Hypertension

Keywords

hypertensionfamily physiciansfixed dose combination therapycluster randomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • The primary measure of outcome is the proportion of subjects treated to target (systolic blood pressure [SBP] <140 mmHg and diastolic blood pressure [DBP] <90 mmHg) at 6 months, compared at the practice level.

Secondary Outcomes (2)

  • Secondary measures of response will include the change at 6 months in systolic blood pressure and diastolic blood pressure. These outcomes will be compared at the practice level

  • Provider satisfaction will be obtained by means of a questionnaire administered at each practice after the last study participant completes the study.

Interventions

fixed dose combination therapyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects 18 years or older
  • Hypertension SBP ≥ 140 mmHg or DBP ≥ 90 mmHg whether untreated or partially treated
  • Absence of ischemic heart disease, atrial fibrillation, peripheral vascular disease, stroke and chronic kidney disease
  • Not participating in other hypertension studies
  • Ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robarts Research Institute

London, Ontario, N6A 5K8, Canada

Location

Related Publications (4)

  • Kirkland SA, MacLean DR, Langille DB, Joffres MR, MacPherson KM, Andreou P. Knowledge and awareness of risk factors for cardiovascular disease among Canadians 55 to 74 years of age: results from the Canadian Heart Health Surveys, 1986-1992. CMAJ. 1999;161(8 Suppl):S10-6.

    PMID: 10551207BACKGROUND

  • Berlowitz DR, Ash AS, Hickey EC, Friedman RH, Glickman M, Kader B, Moskowitz MA. Inadequate management of blood pressure in a hypertensive population. N Engl J Med. 1998 Dec 31;339(27):1957-63. doi: 10.1056/NEJM199812313392701.

    PMID: 9869666BACKGROUND

  • Khan NA, McAlister FA, Campbell NR, Feldman RD, Rabkin S, Mahon J, Lewanczuk R, Zarnke KB, Hemmelgarn B, Lebel M, Levine M, Herbert C; Canadian Hypertension Education Program. The 2004 Canadian recommendations for the management of hypertension: Part II--Therapy. Can J Cardiol. 2004 Jan;20(1):41-54.

    PMID: 14968142BACKGROUND

  • ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97. doi: 10.1001/jama.288.23.2981.

    PMID: 12479763BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ross D Feldman, MD

    Western University, Canada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2005

First Posted

August 12, 2005

Study Start

May 1, 2005

Primary Completion

September 1, 2006

Study Completion

January 1, 2007

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

CA(1)