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Carvedilol modified release formulation

Phase 3

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

Target and mechanism

ModalitySmall molecule

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

Clinical trial landscape

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
Hypertension
NCT00273052514
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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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Competitive Landscape -Hypertension 41 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.CVRX2N/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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