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CompletedNCT00487123Updated Jun 17, 2008

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

A Phase 4 interventional study of Valsartan+/- Hydrochlorothiazide in Hypertension, sponsored by Novartis. Completed at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension, compliance, Valsartan, hydrochlorothiazide (HCTZ)
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with hypertension that have newly started using Valsartan+/-HCTZ

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or Hypersensitivity to Valsartan+/-HCTZ

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • DrugValsartan+/- Hydrochlorothiazide
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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

07

Study locations

1 site
  • Novartis Investigative Site
    Singapore, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00487123
Lead sponsor
Novartis
First posted
Jun 15, 2007
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Jun 17, 2008

Study contacts

non IND
study chair · Sponsor GmbH
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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