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COREG and lisinopril

Phase 1

Hypertension | Small molecule | Cardiovascular |GSK plc|Last Updated: Oct 15, 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 Trials4
Total Enrollment158
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00557128Study to Examine the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination of COREG CR and Lisinopril.PHASE1 COMPLETED 24 — — Nov 1, 2007Dec 1, 2007Oct 15, 20101 United States
NCT00549510Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.PHASE1 COMPLETED 29 — — Oct 1, 2007Dec 1, 2007Oct 15, 20101 United States
NCT00556920Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its ComponentsPHASE1 COMPLETED 50 — — Oct 1, 2007Dec 1, 2007Oct 15, 20101 United States
NCT00552708A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.PHASE1 COMPLETED 55 — — Sep 1, 2007Dec 1, 2007Oct 15, 20101 United States
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Study Endpoints
Primary Endpoints
The effect of food on PK after high fat and standard meal Blood sampling over a 72 hour period post dose in all dosing sessions
72 hour period post dose in all dosing sessions
Assessment of dose proportionality by comparison of PK parameters across dosing range Blood sampling over up to a 120 hour period post dose in all dosing sessions
Blood Sampling over a period of 96 hours post dosing of Investigational product in all sessions. Safety: ECG, Vital Signs, clinical labs over 96 hours post dosing. Continuous Adverse event monitoring from dosing until study conclusion and followup.
96 hours
To establish bioequivalence of the final FDC product (80 mg carvedilol CR/10 mg lisinopril) relative to concomitant dosing of COREG CR (80 mg) and ZESTRIL (10 mg, over encapsulated)throughout the study
throughout the study
Secondary Endpoints
Food effect on PK over 72 hours after meals compared to fasting, safety and tolerability assessed by spontaneous Adverse Event reporting, nurse/physician observations, vital sign assessment, ECGs, and clinical labs over 3 session crossover
72 hours after meals
Other pertinent pharmacokinetic parameters of carvedilol and lisinopril, as data permit, such as Tmax and t1/2 of carvedilol and Tmax and t1/2 of lisinopril
Characterization of PK, safety and tolerability Safety and tolerability will be assessed by clinical data from spontaneous Adverse Event reporting, nurse/physician observations, vital sign assessment, ECGs, and clinical laboratory tests
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
COREG CR and lisinopril (FDC)DRUG -
COREG CRDRUG -
LisinoprilDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Healthy volunteer Adult males and females of non-child bearing potential who are between 18 to 55 years of age, inclusively * Body weight \> 60 kg (132 lbs) and body mass index (BMI) between 19 and 33 Exclusion criteria: * Any clinically relevant abnormality identified on th...

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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