A Randomized, Open-label, Multicentric Parallel Group Study to Assess the Impact of Supportive Measures on the Drug Adherence of Patients With Essential Hypertension Treated With Valsartan or Valsartan Plus HCTZ for 34 Weeks With or Without Respective Measures

Novartis1 site in 1 country206 target enrollmentNovember 2005

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 206
Locations: 1
Primary Endpoint: Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)
Status: Completed
Last Updated: 8 years ago

The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

June 2007

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•Male or female patients \>= 18 years
•Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
•Patients with mild essential hypertension: Systolic blood pressure ≥ 140 mmHg and \< 170 and/or diastolic blood pressure ≥ 90 mmHg and \< 105 mmHg"

•Moderate and severe hypertension
•Pregnant or nursing women
•A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
•Other protocol-defined inclusion/exclusion criteria may apply

Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)

HCTZ 12.5 mg.
Compliance and persistence between randomized groups over time.
To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy
To assess the relation between drug exposure and BP reduction.
To assess the relation between drug exposure and the likelihood to switch to valsartan 160 mg plus HCTZ 12.5 mg
To assess the safety and tolerability of valsartan 160 mg and valsartan 160 mg plus