Clinical trial NCT00902304: Valsartan Intensified Primary Care Reduction of Blood Pressure Study
Official title: A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Baker Heart and Diabetes Institute
First posted: 2009-05-15
Enrollment: 2337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target
timeFrame: 26 weeks
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure
timeFrame: Baseline and 26 weeks
measure: Change in Mean Sitting Diastolic Blood Pressure
timeFrame: Baseline and 26 weeks
measure: Change in Absolute Cardiovascular Risk Score
timeFrame: Baseline and 26 weeks
measure: Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy
timeFrame: 26 weeks
measure: Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments
timeFrame: 26 weeks
measure: Change in the EQ-5D Score
timeFrame: Baseline and 26 weeks
measure: Number of Patients With Depression
timeFrame: Baseline and week 26
measure: Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26
timeFrame: Baseline and week 26
measure: Participants With End Organ Disease at Baseline and Week 26
timeFrame: Baseline and week 26
measure: Change in Self-care Behavior Score From Baseline to Week 26
timeFrame: Baseline and week 26
measure: Rate of Treatment Compliance
timeFrame: 26 weeks
measure: Number of Patients With Major Clinical Endpoints
timeFrame: 26 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Melbourne
country: Australia
facility: Professor Garry Jennings-Co Principal Investigator
city: Melbourne
country: Australia
facility: Professor Simon Stewart-Principal Investigator
Study officials:
affiliation: Novartis Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: