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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00394823

Enrollment

206

Registered

2006-11-01

Start date

2005-11-30

Completion date

2007-06-30

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, valsartan, compliance

Brief summary

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

Interventions

BEHAVIORALSet of supportive tools/measures vs. standard care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—
Compliance and persistence between randomized groups over time.	—
To assess the safety and tolerability of valsartan 160 mg and valsartan 160 mg plus	—
HCTZ 12.5 mg.	—
To assess the relation between drug exposure and the likelihood to switch to valsartan 160 mg plus HCTZ 12.5 mg	—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026