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

Sponsors and Collaborators:	Robarts Research Institute Pfizer
Information provided by:	Robarts Research Institute
ClinicalTrials.gov Identifier:	NCT00637078

Purpose

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol High Blood Pressure

Drug Information available for: Spironolactone Amlodipine Caduet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of a Primary Treatment Algorithm Using Combination Therapy for the Management of Patients With Hypertension and Hypercholesterolemia

Further study details as provided by Robarts Research Institute:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	2500
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: No Intervention Guidelines based management

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637078

Locations

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

Sponsors and Collaborators

Robarts Research Institute

Pfizer

Investigators

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

More Information

No publications provided

Responsible Party:	Robarts Research Institute and London Health Sciences (Dr. Dresser) ( Ross Feldman, MD and George Dresser, MD )
Study ID Numbers:	RPO702
Study First Received:	March 3, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00637078 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Robarts Research Institute:

hypertension
hypercholesterolemia
family physicians
fixed dose combination therapy
cluster randomized controlled trial

Study placed in the following topic categories:

Hyperlipidemias
Metabolic Diseases
Hormone Antagonists
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hormones

Spironolactone
Amlodipine
Aldosterone Antagonists
Angiotensin-Converting Enzyme Inhibitors
Hypercholesterolemia
Metabolic Disorder
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Hyperlipidemias
Metabolic Diseases
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions

Spironolactone
Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009