STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)
STITCH2
Evaluation of a Primary Treatment Algorithm Using Combination Therapy for the Management of Patients With Hypertension and Hypercholesterolemia
1 other identifier
interventional
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
Started Feb 2008
Typical duration for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 3, 2008
CompletedFirst Posted
Study publicly available on registry
March 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 14, 2012
June 1, 2012
2.3 years
March 3, 2008
June 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
Secondary measures include the change at 6 months in SBP and DBP and cholesterol levels. These outcomes will be compared at the practice level
6 months
Study Arms (2)
1
ACTIVE COMPARATORDrug: Fix dose combination therapy
2
NO INTERVENTIONGuidelines based management
Interventions
initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination followed by a low dose DHP-CCB/statin combination
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Western Ontario, Canadalead
- Pfizercollaborator
Study Sites (1)
Robarts Research Insititute
London, Ontario, N6A 5K8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ross Feldman, MD
Deputy Director
- PRINCIPAL INVESTIGATOR
George Dresser, MD
Co prinicipal investigator
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
March 3, 2008
First Posted
March 17, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2010
Study Completion
December 1, 2010
Last Updated
June 14, 2012
Record last verified: 2012-06