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SK&F-105517

Phase 1

Hypertension | Small molecule | Cardiovascular |GSK plc|Last Updated: Oct 19, 2010

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00537043A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood PressurePHASE1 COMPLETED 24 — — Oct 1, 2007Jan 1, 2008Oct 19, 20102 United States
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Study Endpoints
Primary Endpoints
Comparison of the amount of SB-568859 found in the blood after a 7 days of dosing with carvedilol controlled release and carvedilol controlled release plus lisinopril
7 days
Secondary Endpoints
Assessment of the safety and tolerability of carvedilol controlled release and the fixed dose combination based on blood and urine tests, vital signs, and reporting of side effects.
7 days
The pharmacokinetic parameters to be evaluated are the Tmax, Ct, and t1/2 of carvedilol [R(+)- and S(-)-enantiomers] when administered as the FDC formulation compared to COREG CR alone.
Safety and tolerability as assessed by clinical data from AE reporting, nurse/physician observations, vital signs, ECGs and safety laboratory tests.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
SK&F-105517 (COREG CR FDC)DRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Adult males or females of non-child bearing potential who are between 18 and 60 years old. * Have a history of mild to moderate essential hypertension or present with mild to moderate essential hypertension defined by Diastolic Blood Pressure \>/90 and \</109 mmHg, and/or Syst...

Countries:United States
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Competitive Landscape -Hypertension 42 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron, LY3971297
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran, ALN-AGT01 RVR
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS3PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN3 — Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Novo Nordisk A/S Sponsored ADR Class BNVO1 — Undisclosed
Orchestra BioMed Holdings, Inc.OBIO3NAUndisclosed
CVRx, Inc.CVRX1NAMedical Management
Medtronic PlcMDT4NAUndisclosed
IQVIA Holdings IncIQV1NAUndisclosed
Verve Medical, IncVERV1NAActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1NATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
Harvard Bioscience, Inc.HBIO1 — Undisclosed
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