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

This study has been completed.

First Received: June 13, 2007 Last Updated: June 13, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00487123

Purpose

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	Intervention	Phase
Hypertension	Drug: Valsartan+/- Hydrochlorothiazide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487123

Locations

Singapore
Novartis Investigative Site
singapore, Singapore

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

non IND

Sponsor GmbH

More Information

No publications provided

Study ID Numbers:	CVAH631BSG02
Study First Received:	June 13, 2007
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00487123 History of Changes
Health Authority:	United States: Food and Drug Administration; Singapore: Health Sciences Authority

Keywords provided by Novartis:

Hypertension, compliance, Valsartan, hydrochlorothiazide (HCTZ)

Study placed in the following topic categories:

Essential Hypertension
Sodium Chloride Symporter Inhibitors
Diuretics
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Hydrochlorothiazide
Valsartan
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009