STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia) - Tabular View

Tracking Information

First Received Date ^ICMJE

March 3, 2008

Last Updated Date

February 3, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00637078 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

Official Title ^ICMJE

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

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hypertension
Hypercholesterolemia

Intervention ^ICMJE

Other: Treatment algorithm:caduet, Amlodipine, ACEI-ARB combo dose, a-blocker, b-blocker or spironolactone, dyslipidemic therapy with ezetamide

Study Arms / Comparison Groups

Active Comparator: Drug: Fix dose combination therapy
No Intervention: Guidelines based management

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

2500

Estimated Completion Date

March 2010

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00637078

Responsible Party

Ross Feldman, MD and George Dresser, MD, Robarts Research Institute and London Health Sciences (Dr. Dresser)

Study ID Numbers ^ICMJE

RPO702

Study Sponsor ^ICMJE

Robarts Research Institute

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

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

Information Provided By

Robarts Research Institute

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP