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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394823
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : May 18, 2017
Information provided by:

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
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
Study Start Date : November 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

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

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00394823

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Investigative Centers, Germany
Basel, Switzerland
Sponsors and Collaborators
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Study Chair: Novartis Basel +41 61 324 1111
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00394823    
Other Study ID Numbers: CVAL489ADE24
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Keywords provided by Novartis:
Hypertension, valsartan, compliance
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases