Efficacy of the New Closure Device in Improving Patient Compliance in Treatment of Hypertension With Valsartan+/-Hydrochlorothiazide (HCTZ) at 6 Months
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan+/- Hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
non IND, Study Chair, Affiliation: Sponsor GmbH
Summary
This study will evaluate the efficacy of the reminder device Remind Cap® in improving
patients' compliance in the consumption of Valsartan +/- Hydrochlorothiazide (HCTZ) in the
treatment of hypertension
Clinical Details
Official title: A Multi-Center, Randomized, Proof-of-Concept, Parallel Control Study With Remind Cap® in Patients With Essential Hypertension and Newly Treated With Valsartan+/-Hydrochlorothiazide (HCTZ)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Compliance rate at month 3, 6 and post study month 1 will be assessed by pill count
Secondary outcome: Patient Adherence to study/follow up visits -Clinical Outcome Measurement: Mean sitting systolic BP and mean sitting diastolic BP -Patient's and Physician's Satisfaction Survey
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with hypertension that have newly started using Valsartan+/-HCTZ
Exclusion Criteria:
- Pregnancy or Hypersensitivity to Valsartan+/-HCTZ
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Investigative Site, Singapore, Singapore
Additional Information
Last updated: June 13, 2008
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