STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

Hypertension Clinical Trial

— STITCH2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637078
• Other study ID #: RPO702
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2008
• Last updated: June 13, 2012
• Start date: February 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: University of Western Ontario, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Canada	Robarts Research Insititute	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No