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SPP100

Phase 2

Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Dec 21, 2020

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment334
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00246584A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)PHASE2 COMPLETED 300Oct 1, 2004 -Jul 28, 20061 Switzerland
NCT00424541Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential HypertensionPHASE1 COMPLETED 34Jan 1, 2007Aug 1, 2007Dec 21, 20201 Japan
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Study Endpoints
Primary Endpoints
Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28
Secondary Endpoints
Change from baseline in diastolic blood pressure after 52 weeks
Change from baseline in systolic blood pressure after 52 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SPP100DRUG -
SPP100 (aliskiren)DRUG -
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Eligibility Criteria
Age Range20 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed as essential hypertension - Exclusion Criteria: * Patients with secondary hypertension or suspected of having secondary hypertension. * Patients suspected of having malignant hypertension * Patients with any serious diseases or symptoms

Countries:SwitzerlandJapan
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