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NCT00487123 Clinical Trial

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

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00487123
Other study ID # CVAH631BSG02
Secondary ID
Status Completed
Phase Phase 4
First received June 13, 2007
Last updated June 13, 2008
Est. completion date September 2007

Study information
Verified date June 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationSingapore: Health Sciences Authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Valsartan+/- Hydrochlorothiazide

Locations
Country Name City State
Singapore Novartis Investigative Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compliance rate at month 3, 6 and post study month 1 will be assessed by pill count
Secondary 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
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