Official Title: “Evaluation of a Primary Treatment Algorithm Using Combination Therapy for the Management of Patients With Hypertension and Hypercholesterolemia”

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.

Study Type: Interventional

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

Study Primary Completion Date: October 2009

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Drug: Fix dose combination therapy
• No Intervention: 2
  • Guidelines based management

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Robarts Research Institute

Overall Clinical Trial Officials and Contacts

Ross Feldman, MD Principal Investigator Deputy Director  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637078

Study ID Number: RPO702

ClinicalTrials.gov Identifier: NCT00637078

Health Authority: Canada: Health Canada