A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy
Overview
- Phase
- Phase 4
- Intervention
- Usual care
- Conditions
- Hypertension
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 2337
- Locations
- 3
- Primary Endpoint
- Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.
Investigators
Eligibility Criteria
Inclusion Criteria
- •newly diagnosed or currently treated hypertensive patients who have not attained their blood pressure target and require active pharmacological treatment as recommended by the local guidelines as judged by the general practitioner
Exclusion Criteria
- •significantly elevated blood pressure (severe hypertension)
- •requiring 3 or more antihypertensive drugs
- •severe kidney disease or dialyses
- •clinical diagnosis requiring concomitant therapy with antihypertensive treatment that would be outside the therapies allowed under study protocol
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
Usual care
Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
Intervention: Usual care
Monotherapy (initial monotherapy arm)
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Intervention: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy
Monotherapy (initial monotherapy arm)
Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Intervention: Valsartan
Combination (initial combination therapy arm)
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Intervention: Valsartan and amlodipine
Combination (initial combination therapy arm)
Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Intervention: Valsartan and hydrochlorothiazide (HCTZ) - combination arm
Outcomes
Primary Outcomes
Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
Time Frame: 26 weeks
BP target groups were: \<= 125/75mmHg, \<= 130/80mmHg and \<= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.
Secondary Outcomes
- Change in Mean Sitting Systolic Blood Pressure(Baseline and 26 weeks)
- Change in Mean Sitting Diastolic Blood Pressure(Baseline and 26 weeks)
- Change in Absolute Cardiovascular Risk Score(Baseline and 26 weeks)
- Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy(26 weeks)
- Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments(26 weeks)
- Change in the EQ-5D Score(Baseline and 26 weeks)
- Number of Patients With Depression(Baseline and week 26)
- Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26(Baseline and week 26)
- Participants With End Organ Disease at Baseline and Week 26(Baseline and week 26)
- Change in Self-care Behavior Score From Baseline to Week 26(Baseline and week 26)
- Rate of Treatment Compliance(26 weeks)
- Number of Patients With Major Clinical Endpoints(26 weeks)