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Amlodipine- reference

Phase 3

Hypertension | Small molecule | Cardiovascular |Viatris Inc.|Trials Updated: Apr 24, 2024

Amlodipine- reference target and mechanism

Molecular targetCACNA1C, CACNA1S, CACNA1D, CACNA1F
Target classBlocker
ModalitySmall molecule

Also known as Amlodipine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials5
Total Enrollment3,609

FDA Designations

No designations recorded

Amlodipine- reference clinical trials

Amlodipine- reference · 5 trials · 5 indications

Phase 3 4Phase 1 1
NCT00530946A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And AtorvastatinHypertension
COMPLETED165 Analytics
NCT00415623A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is InsufficientHypertension
COMPLETED305 Analytics
NCT00330785Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and DyslipidaemiaHypertension
COMPLETED1,250 Analytics
NCT00143234Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol LevelsHypertension
COMPLETED1,825 Analytics
PHASE3COMPLETED
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
HypertensionUnlock trial analytics
PHASE3COMPLETED
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
HypertensionUnlock trial analytics
PHASE3COMPLETED
Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia
HypertensionUnlock trial analytics
PHASE3COMPLETED
Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Systolic Blood Pressure
8 weeks

Value at Week 8 minus value at baseline

Percent Change in Low Density Lipoprotein-Cholesterol
8 weeks

Percent of "value at Week 8 minus value at baseline" over value at baseline

Change in Systolic Blood Pressure (SBP) From Baseline to Week 8
Baseline to Week 8

Mean change in the trough SBP

To evaluate the number of patients who reach target blood pressure (BP) and
LDL-C targets as defined by their governing guidelines.
To evaluate the efficacy of amlodipine/atorvastatin therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III)
Bioequivalence
within 30 days

Secondary Endpoints

Change in Systolic Blood Pressure From Baseline to Each Observation Point
2 weeks, 4 weeks, and 8 weeks
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
2 weeks, 4 weeks , and 8 weeks
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
2 weeks, 4 weeks , and 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CI-1038 2.5mg/5mgACTIVE_COMPARATOR -
CI-1038 2.5mg/10mgACTIVE_COMPARATOR -
CI-1038 5mg/5mgACTIVE_COMPARATOR -
CI-1038 5mg/10mgACTIVE_COMPARATOR -
Amlodipine 5mgACTIVE_COMPARATOR -
Amlodipine 10mgEXPERIMENTAL -
1EXPERIMENTALAmlodipine and Benazepril HCl Capsules 10 mg/20 mg
2ACTIVE_COMPARATORLotrel® Capsules 10 mg/20 mg

Interventions

NameTypeDescription
Amlodipine 2.5mg/Atorvastatin 5mgDRUGSingle pill combination, dosed once daily for 8 weeks
Amlodipine 2.5mg/Atorvastatin 10mgDRUGSingle pill combination, dosed once daily for 8 weeks
Amlodipine 5mg/Atorvastatin 5mgDRUGSingle pill combination, dosed once daily for 8 weeks
Amlodipine 5mg/Atorvastatin 10mgDRUGSingle pill combination, dosed once daily for 8 weeks
AmlodipineDRUGAmlodipine 5mg/ day
Amlodipine/AtorvastatinDRUG -
Amlodipine/atorvastatin single pillDRUG -
Amlodipine and Benazepril HCl Capsules 10 mg/20 mgDRUG10/120mg, single dose fed
Lotrel® Capsules 10 mg/20 mgDRUG10/20mg, single dose fed
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Eligibility Criteria

Age Range20 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female \>=20 to \<80 years of age at Visit 1. * The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP \>=140 mmHg and \<180 mmHg, * LDL-C \>=140 mg/dL and \<250 mg/dL at Vis...

Countries:JapanCanadaUnited KingdomArgentinaAustraliaBrazilChileGuatemalaHong KongIndiaIndonesiaIsraelJordanKuwaitLebanonMalaysiaMexicoMoroccoPakistanPeruPhilippinesSaudi ArabiaSingaporeSouth AfricaSouth KoreaTaiwanThailandTunisiaTurkey (Türkiye)United Arab EmiratesUnited States
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Frequently asked questions about Amlodipine- reference

What is Amlodipine and Benazepril?

Amlodipine and Benazepril is a fixed dose combination product developed by Viatris Inc. (ticker VTRS). It combines amlodipine, a calcium channel blocker, with benazepril, an ACE inhibitor, in a single oral capsule. The specific presentation referenced here is Amlodipine and Benazepril HCl Capsules 10 mg/20 mg.

What does Amlodipine and Benazepril target?

Amlodipine and Benazepril targets the calcium channel subunits CACNA1C, CACNA1S, CACNA1D, and CACNA1F. Amlodipine acts as a blocker at these L type calcium channels, while benazepril is an ACE inhibitor. This dual mechanism is intended to lower blood pressure through complementary pathways.

Who makes Amlodipine and Benazepril?

Amlodipine and Benazepril is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the company associated with the Amlodipine and Benazepril HCl Capsules 10 mg/20 mg presentation described in this reference.

What phase is Amlodipine and Benazepril in?

Amlodipine and Benazepril is in Phase 1 development. The single registered trial for this asset is a Phase 1 study, and it has been completed. The program is not currently active, with no ongoing trials listed.

What clinical trials is Amlodipine and Benazepril in?

Amlodipine and Benazepril has been studied in one completed Phase 1 trial, NCT00649402, titled Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel Capsules 10 mg/20 mg. The trial enrolled 64 healthy adult volunteers in the United States and used an active controlled, randomized design.