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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: October 31, 2006
Last updated: May 16, 2017
Last verified: May 2017
The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension

Condition Intervention Phase
Hypertension Behavioral: Set of supportive tools/measures vs. standard care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)

Secondary Outcome Measures:
  • 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
  • HCTZ 12.5 mg.

Enrollment: 206
Study Start Date: November 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00394823

Investigative Centers, Germany
Basel, Switzerland
Sponsors and Collaborators
Study Chair: Novartis Basel +41 61 324 1111
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00394823     History of Changes
Other Study ID Numbers: CVAL489ADE24
Study First Received: October 31, 2006
Last Updated: May 16, 2017

Keywords provided by Novartis:
Hypertension, valsartan, compliance

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on August 23, 2017