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COREG and lisinopril

Phase 1

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

COREG and lisinopril target and mechanism

ModalitySmall molecule

Also known as COREG CR, COREG

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials4
Total Enrollment158

FDA Designations

No designations recorded

COREG and lisinopril clinical trials

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.
HypertensionUnlock trial analytics
PHASE1COMPLETED
Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.
HypertensionUnlock trial analytics
PHASE1COMPLETED
Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components
HypertensionUnlock trial analytics
PHASE1COMPLETED
A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.
HypertensionUnlock trial analytics

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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Frequently asked questions about COREG and lisinopril

What is COREG and lisinopril?

COREG and lisinopril refers to a fixed dose combination product candidate that pairs COREG CR, the extended release form of carvedilol, with lisinopril. It is being developed for hypertension, also known as high blood pressure, and is a small molecule combination therapy. The program is being advanced by GSK plc.

What is COREG and lisinopril used for in hypertension?

COREG and lisinopril is being developed for the treatment of hypertension. The fixed dose combination is intended to combine COREG CR, an extended release beta blocker, with lisinopril, an ACE inhibitor, in a single product. It remains investigational and is not approved for use in hypertension.

Who makes COREG and lisinopril?

COREG and lisinopril is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the fixed dose combination of COREG CR and lisinopril for hypertension.

What phase is COREG and lisinopril in?

COREG and lisinopril is in Phase 1 clinical development. All four of its recorded trials are Phase 1 studies, and all four are completed. No active trials are ongoing. The program is investigational and has not been approved for any indication.

What clinical trials is COREG and lisinopril in?

COREG and lisinopril has been studied in four completed Phase 1 trials: NCT00557128, which examined the effect of food on pharmacokinetics; NCT00556920, which assessed bioequivalence to its components; NCT00552708, which investigated bioequivalence of the fixed dose combination; and NCT00549510, which investigated dose proportionality.

Is COREG and lisinopril the same as COREG CR?

No. COREG and lisinopril is a fixed dose combination product that pairs COREG CR with lisinopril. COREG CR on its own is the extended release form of carvedilol and is one component of the combination. The combination is also referred to as COREG CR and lisinopril (FDC).