STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia) (STITCH2)

June 13, 2012 updated by: University of Western Ontario, Canada

Evaluation of a Primary Treatment Algorithm Using Combination Therapy for the Management of Patients With Hypertension and Hypercholesterolemia

The objective of this study is to assess if the implementation of a treatment algorithm including initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination and subsequently a low dose DHP-CCB/statin combination will improve the management of hypertension/hypercholesterolemia compared to guidelines-base management at family practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Utilization of fixed dose combination therapy has been advocated as an adherence-enhancing strategy and has been so recommended in the 2007 Canadian Hypertension Education Program (CHEP) recommendations. Further, in a previous study (STITCH) it was demonstrated that a simplified treatment algorithm utilizing initial therapy with a low dose fixed-dose combination therapy improved blood pressure control in hypertensive patients. However, the effectiveness of either a simplified treatment algorithm or the initial use of fixed dose combination therapies for 2 risk factors in hypertensive dyslipidemic patients has yet to be determined. Therefore, the current study is designed to determine whether utilization of a fixed dose combination hypertension/hypercholesterolemia therapy results in improved adherence, patient satisfaction as well as improved rates of reaching target LDL cholesterol and blood pressure.

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 4

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5K8
        • Robarts Research Insititute

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female subjects 18 years or older
  • documented diagnoses of hypertension and of hypercholesterolemia or current therapy for these conditions
  • uncontrolled hypertension (SBP >140 mmHg or DBP >90 mmHg) or cholesterol levels above their threshold based on their global atherosclerotic risk profile (based on ATP III assessment)
  • ability to give written informed consent

Exclusion Criteria:

  • ischemic heart disease, atrial fibrillation, chronic kidney disease and significant liver disease
  • currently prescribed 3 or more drugs to control blood pressure
  • currently prescribed 2 or more drugs to control hypercholesterolemia
  • participating in other hypertension/hypercholesterolemia studies

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Drug: Fix dose combination therapy
Other: Treatment algorithm:caduet, Amlodipine, ACEI-ARB combo dose, a-blocker, b-blocker or spironolactone, dyslipidemic therapy with ezetamide
initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination followed by a low dose DHP-CCB/statin combination
No Intervention: 2
Guidelines based management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects whose systolic BP [SBP] <140 mmHg and diastolic BP [DBP] <90 mmHg)or proportion whose cholesterol levels are at or below threshold based on their global artherosclerotic risk profile compared at the practice level.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary measures include the change at 6 months in SBP and DBP and cholesterol levels. These outcomes will be compared at the practice level
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Collaborators

Pfizer

Investigators

  • Principal Investigator: Ross Feldman, MD, Deputy Director
  • Principal Investigator: George Dresser, MD, Co prinicipal investigator

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

February 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 14, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPO702

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.

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