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COREG and lisinopril

Phase 1

Hypertension | Small molecule | Cardiovascular |GSK plc|Last Updated: Oct 15, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials4
Total Enrollment158

FDA Designations

No designations recorded

Clinical trial landscape

COREG and lisinopril · 4 trials · 1 indication

Phase 1 4
NCT00557128Study to Examine the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination of COREG CR and Lisinopril.Hypertension
COMPLETED24 Analytics
NCT00549510Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.Hypertension
COMPLETED29 Analytics
NCT00556920Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its ComponentsHypertension
COMPLETED50 Analytics
NCT00552708A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.Hypertension
COMPLETED55 Analytics
PHASE1COMPLETED
Study to Examine the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination of COREG CR and Lisinopril.
Hypertension
NCT0055712824
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PHASE1COMPLETED
Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.
Hypertension
NCT0054951029
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PHASE1COMPLETED
Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components
Hypertension
NCT0055692050
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PHASE1COMPLETED
A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.
Hypertension
NCT0055270855
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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 to 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 40 trials

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS2PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN2 - Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Orchestra BioMed Holdings, Inc.OBIO3N/AUndisclosed
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
CVRx, Inc.CVRX1N/AMedical Management
Medtronic PlcMDT4N/AUndisclosed
IQVIA Holdings IncIQV1N/AUndisclosed
Verve Medical, IncVERV1N/AActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1N/ATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
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Frequently asked questions about COREG and lisinopril

What is COREG and lisinopril used for?

COREG and lisinopril is a fixed-dose combination of the drugs carvedilol and lisinopril, being studied for the treatment of hypertension. It is an investigational small-molecule therapy in Phase 1 clinical development, intended to combine the blood pressure-lowering effects of both medications into a single product.

Who makes COREG and lisinopril?

COREG and lisinopril is being developed by GSK plc, which trades under the ticker GSK. The company is conducting Phase 1 clinical trials to evaluate the fixed-dose combination of carvedilol and lisinopril for the treatment of hypertension.

What phase is COREG and lisinopril in?

COREG and lisinopril is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Four Phase 1 trials have been completed, with no active trials currently ongoing, and the drug remains under investigation for hypertension.

What clinical trials is COREG and lisinopril in?

COREG and lisinopril has completed four Phase 1 clinical trials: NCT00549510, NCT00552708, NCT00556920, and NCT00557128. These studies enrolled a total of 158 participants and investigated dose proportionality, bioequivalence, and the effect of food on the fixed-dose combination in healthy volunteers.

Is COREG and lisinopril the same as COREG CR and ZESTRIL?

COREG and lisinopril is a fixed-dose combination of carvedilol and lisinopril. One clinical trial, NCT00552708, specifically investigated the bioequivalence of this combination compared to taking COREG CR and ZESTRIL separately, but the drug itself is a distinct fixed-dose combination product.