VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients
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|ClinicalTrials.gov Identifier: NCT00394823|
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Set of supportive tools/measures vs. standard care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
- Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00394823
|Investigative Centers, Germany|
|Study Chair:||Novartis Basel||+41 61 324 1111|