VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients
This study has been completed.
Information provided by:
First received: October 31, 2006
Last updated: November 7, 2011
Last verified: November 2011
The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension
Behavioral: Set of supportive tools/measures vs. standard care
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|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:
U.S. FDA Resources
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.
|Study Start Date:||November 2005|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
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