Efficacy of the New Closure Device in Improving Patient Compliance in Treatment of Hypertension With Valsartan+/-Hydrochlorothiazide (HCTZ) at 6 Months

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00487123
• Lead Sponsor: Novartis

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-13
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-15
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-13
• Last Update Posted: 2008-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compliance rate at month 3, 6 and post study month 1 will be assessed by pill count

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇸🇬 Singapore, Singapore