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Carvedilol modified release formulation

Phase 3

Hypertension | Small molecule | Cardiovascular |GSK plc|Trials Updated: Jun 25, 2018

Carvedilol modified release formulation target and mechanism

Molecular targetADRA1A, ADRA1D, ADRA1B, ADRB1, ADRB2, ADRB3
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL723

Also known as Carvedilol Phosphate modified release formulation

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment514

FDA Designations

No designations recorded

Carvedilol modified release formulation clinical trials

Carvedilol modified release formulation · 1 trial · 1 indication

Phase 3 1
NCT00273052COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With HypertensionHypertension
COMPLETED514 Analytics
PHASE3COMPLETED
COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6
Baseline and Month 6

Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.

Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6
Baseline and Month 6

Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.

Secondary Endpoints

Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6
Baseline and Month 6
Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6
Baseline and Month 6
Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6
Baseline and Month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Carvedilol Phosphate modified release formulationEXPERIMENTAL -
metoprolol succinateACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Carvedilol Phosphate modified release formulationDRUG -
metoprolol succinateDRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites120

Inclusion Criteria: * Documented history of hypertension * Triglycerides of 120-400 mg/mL * LDLc levels not requiring lipid lowering medication. Exclusion Criteria: * Has known contraindication to alpha- or beta-blocker therapy. * Has taken any non-ocular beta-blockers within three months before ...

Countries:United StatesCanadaPuerto Rico
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Frequently asked questions about Carvedilol modified release formulation

What is carvedilol modified release formulation?

Carvedilol modified release formulation is an investigational small molecule developed by GSK plc for hypertension. It is a once-daily extended-release version of carvedilol, also known as carvedilol phosphate modified release. It has completed Phase 3 clinical testing in adults with hypertension, including patients with normal or mildly elevated lipid levels.

What is carvedilol modified release formulation used for?

Carvedilol modified release formulation is being developed for the treatment of hypertension, or high blood pressure. Its Phase 3 trial enrolled adults 18 years and older with hypertension, including patients who were normolipidemic or mildly dyslipidemic. The program is focused on cardiovascular medicine.

What does carvedilol modified release formulation target?

Carvedilol modified release formulation targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D, and the beta-adrenergic receptors ADRB1, ADRB2, and ADRB3. It acts as an antagonist at these receptors, which is the mechanism associated with its blood pressure lowering activity in hypertension.

Who makes carvedilol modified release formulation?

GSK plc, which trades under the ticker GSK, is the developer of carvedilol modified release formulation. The company sponsored the Phase 3 trial evaluating the asset in hypertension. GSK is the company name associated with this modified release carvedilol phosphate program.

What phase is carvedilol modified release formulation in?

Carvedilol modified release formulation has completed Phase 3 clinical development. It is an investigational product and is not described as FDA approved. The single Phase 3 trial, NCT00273052, is listed as completed, and no trials for this formulation are currently active.

What clinical trials is carvedilol modified release formulation in?

Carvedilol modified release formulation was studied in the Phase 3 trial NCT00273052, titled COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension. The trial enrolled 514 participants across the United States, Canada, and Puerto Rico, was randomized, double blind, and active controlled, and is now completed.

Is carvedilol modified release formulation the same as carvedilol phosphate modified release formulation?

Yes. Carvedilol modified release formulation is also known as carvedilol phosphate modified release formulation. Both names refer to the same GSK plc product candidate, a small molecule in Phase 3 development for hypertension. Searches using either name point to the same asset and the same clinical program.