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LCI699

Phase 2

Primary Hyperaldosteronism | Small molecule | Other |Novartis AG|Last Updated: Aug 26, 2009

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00732771Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary HyperaldosteronismPHASE2 COMPLETED 12Jun 1, 2008 -Aug 26, 20091 France
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Study Endpoints
Primary Endpoints
Systolic blood pressure over a 7-week forced titration treatment period
7 weeks
Secondary Endpoints
Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period
7 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LCI696 1mg bidEXPERIMENTAL -
Interventions
NameTypeDescription
LCI699DRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA). * Hypertension at screening Exclusion Criteria: * Persistent hypokalemia * Renal impairment * Significant hepatic disease * Any surgical or me...

Countries:France
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