VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Set of supportive tools/measures vs. standard care (Behavioral)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Basel, Study Chair, Affiliation: +41 61 324 1111
Summary
The purpose of this study is to assess the impact of supportive measures on the drug
adherence of patients with essential hypertension
Clinical Details
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 design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Investigative Centers, Germany
Novartis, Basel, Switzerland
Additional Information
Starting date: November 2005
Last updated: November 7, 2007
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