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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00487123
First received: June 13, 2007
Last updated: June 13, 2008
Last verified: June 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 19, 2014