STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

Sponsor

University of Western Ontario, Canada (Other)

Overall Status

Completed

CT.gov ID

NCT00637078

Collaborator

Pfizer (Industry)

1,000

Enrollment

Location

Arms

Duration (Months)

29.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Hypercholesterolemia	Other: Treatment algorithm:caduet, Amlodipine, ACEI-ARB combo dose, a-blocker, b-blocker or spironolactone, dyslipidemic therapy with ezetamide	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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