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OpenTrials
Completed

NCT Number: NCT00394823

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

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

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Set of supportive tools/measures vs. standard care

Behavioral

Primary outcomes

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

Secondary outcomes

  1. Compliance and persistence between randomized groups over time.

  2. To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy

  3. To assess the relation between drug exposure and BP reduction.

  4. To assess the relation between drug exposure and the likelihood to switch to valsartan 160 mg plus HCTZ 12.5 mg

  5. To assess the safety and tolerability of valsartan 160 mg and valsartan 160 mg plus

  6. HCTZ 12.5 mg.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 1, 2006
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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