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Ali/Amlo 150/

Phase 3

Essential Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Feb 23, 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
UNCONTROLLED
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01237873Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential HypertensionPHASE3 COMPLETED 150 — — Jan 1, 2011Feb 1, 2012Feb 23, 201713 Japan
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Study Endpoints
Primary Endpoints
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
52 weeks

Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.

Secondary Endpoints
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
52 weeks
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study
52 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ali/AmloEXPERIMENTALAliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Interventions
NameTypeDescription
Ali/Amlo 150/2.5 mgDRUGAliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Patients that complete CSPA100A1301 study * Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled Exclusion Criteria: * Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study * Presence of major prot...

Countries:Japan
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