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Set of supportive tools/measures vs. standard care

Phase 3

Hypertension | Unknown | Cardiovascular |Novartis AG|Last Updated: May 18, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment206

FDA Designations

No designations recorded

Clinical trial landscape

Set of supportive tools/measures vs. standard care · 1 trial · 1 indication

Phase 3 1
NCT00394823VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive PatientsHypertension
COMPLETED206 Analytics
PHASE3COMPLETED
VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)

Secondary Endpoints

Compliance and persistence between randomized groups over time.
To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy
To assess the relation between drug exposure and BP reduction.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Interventions

NameTypeDescription
Set of supportive tools/measures vs. standard careBEHAVIORAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female patients \>= 18 years * Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives). * Patients with mild essential hyperten...

Countries:GermanySwitzerland
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Frequently asked questions about Set of supportive tools/measures vs. standard care

What is Set of supportive tools/measures vs. standard care used for?

Set of supportive tools/measures vs. standard care is used for hypertension. It was studied in a Phase 3 clinical trial as an intervention to support drug adherence in treated hypertensive patients. The trial, known as VALIDATE, enrolled 206 participants and was conducted in Germany and Switzerland.

Who makes Set of supportive tools/measures vs. standard care?

Set of supportive tools/measures vs. standard care is developed by Novartis AG, which trades under the ticker NVS. The company sponsored the Phase 3 clinical trial for this intervention in hypertension.

What phase is Set of supportive tools/measures vs. standard care in?

Set of supportive tools/measures vs. standard care is in Phase 3 clinical development. The Phase 3 trial, NCT00394823, has been completed. The intervention is investigational and not approved for use outside of clinical research.

What clinical trials is Set of supportive tools/measures vs. standard care in?

Set of supportive tools/measures vs. standard care has one completed Phase 3 trial, NCT00394823, titled VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients. The trial enrolled 206 adults with hypertension in Germany and Switzerland.

Is Set of supportive tools/measures vs. standard care the same as Valsartan?

Set of supportive tools/measures vs. standard care is not the same as valsartan. The trial combined valsartan with supportive measures, but the intervention being studied is the set of supportive tools or measures compared to standard care, not the drug itself.