Phase 4
Completed N=1,562
Valsartan Intensified Primary Care Reduction of Blood Pressure Study
Source: ClinicalTrials.gov NCT00902304 ↗Enrolled (actual)
1,562
Serious AEs
2.4%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target — 27.4; 33.0; 37.9 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target |
27.4; 33.0; 37.9 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure |
-10; -11.6; -14.4 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure |
-5.45; -6.9; -8.29 | — |
| SECONDARY Change in Absolute Cardiovascular Risk Score |
-2.6; -3.3; -3.9 | — |
| SECONDARY Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy |
70; 70; 169 | — |
| SECONDARY Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments |
3; 3; 6; 27; 14; 34 | — |
| SECONDARY Change in the EQ-5D Score |
-0.007; 0.017; 0.011 | — |
| SECONDARY Number of Patients With Depression |
154; 96; 185; 129; 78; 151 | — |
| SECONDARY Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26 |
1.03; -1.12; 1.19 | — |
| SECONDARY Participants With End Organ Disease at Baseline and Week 26 |
226; 146; 315; 157; 88; 177 | — |
| SECONDARY Change in Self-care Behavior Score From Baseline to Week 26 |
2.59; 2.27; 3.17; 0.93; -0.72; -0.71 | — |
| SECONDARY Rate of Treatment Compliance |
— | — |
| SECONDARY Number of Patients With Major Clinical Endpoints |
0; 1; 0; 15; 6; 13 | — |
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
Data sourced from ClinicalTrials.gov (NCT00902304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.