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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment206
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00394823VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive PatientsPHASE3 COMPLETED 206Nov 1, 2005Jun 1, 2007May 18, 20172 Germany, Switzerland
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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 — 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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