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STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00637078
First received: March 3, 2008
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Western Ontario, Canada:

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 ]

Enrollment: 1000
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
University of Western Ontario, Canada
Pfizer
Investigators
Principal Investigator: Ross Feldman, MD Deputy Director
Principal Investigator: George Dresser, MD Co prinicipal investigator
  More Information

No publications provided

Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00637078     History of Changes
Other Study ID Numbers: RPO702
Study First Received: March 3, 2008
Last Updated: June 13, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Western Ontario, Canada:
hypertension
hypercholesterolemia
family physicians
fixed dose combination therapy
cluster randomized controlled trial

Additional relevant MeSH terms:
Hypercholesterolemia
Hypertension
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Spironolactone
Amlodipine
Aldosterone Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on June 18, 2013