Recent Updates
Recently added Catalysts

SAD448

Phase 1

Ocular Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Apr 24, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00503360Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular HypertensionPHASE1 COMPLETED 80Apr 1, 2007 -Apr 24, 20081 Australia
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs from baseline up to 24 hours post-dosing.
Secondary Endpoints
Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SAD448DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key inclusion criteria: * Males and females, 18 - 65 years of age, with ocular hypertension * Females must be post-menopausal or surgically sterile Key exclusion criteria: * Diagnosis of glaucoma in either eye * A history of or current eye conditions or medical problems that would prohibit the us...

Countries:Australia
Unlock Eligibility Criteria