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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

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. Identifier: NCT00487123
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : June 17, 2008
Information provided by:

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00487123

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Novartis Investigative Site
Singapore, Singapore
Sponsors and Collaborators
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Study Chair: non IND Sponsor GmbH
Layout table for additonal information Identifier: NCT00487123    
Other Study ID Numbers: CVAH631BSG02
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008
Keywords provided by Novartis:
Hypertension, compliance, Valsartan, hydrochlorothiazide (HCTZ)
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators