VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Behavioral: Set of supportive tools/measures vs. standard care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394823

CVAL489ADE24

Details and patient eligibility

About

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

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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"

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)