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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00487123
• Collaborator: (none)
• Location: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Valsartan+/- Hydrochlorothiazide	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. Compliance rate at month 3, 6 and post study month 1 will be assessed by pill count []

Secondary Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Singapore		Singapore

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: non IND, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00487123
• Other Study ID Numbers: CVAH631BSG02
• First Posted: Jun 15, 2007
• Last Update Posted: Jun 17, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Hypertension, compliance, Valsartan, hydrochlorothiazide (HCTZ)
• Additional relevant MeSH terms: Hypertension; Valsartan; Hydrochlorothiazide

Study Results

No Results Posted as of Jun 17, 2008