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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

Page last updated: August 23, 2015

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