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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00487123
First Posted: June 15, 2007
Last Update Posted: June 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487123


Locations
Singapore
Novartis Investigative Site
Singapore, Singapore
Sponsors and Collaborators
Novartis
Investigators
Study Chair: non IND Sponsor GmbH
  More Information

ClinicalTrials.gov Identifier: NCT00487123     History of Changes
Other Study ID Numbers: CVAH631BSG02
First Submitted: June 13, 2007
First Posted: June 15, 2007
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Novartis:
Hypertension, compliance, Valsartan, hydrochlorothiazide (HCTZ)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators