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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00487123

Enrollment

Unknown

Registered

2007-06-15

Start date

Unknown

Completion date

2007-09-30

Last updated

2008-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, compliance, Valsartan, hydrochlorothiazide (HCTZ)

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

Interventions

DRUGValsartan+/- Hydrochlorothiazide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Pregnancy or Hypersensitivity to Valsartan+/-HCTZ Other protocol-defined inclusion/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026