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Amlodipine- reference

Phase 3

Hypertension | Small molecule | Cardiovascular |Pfizer, Inc.|Trials Updated: Feb 11, 2021

Amlodipine- reference target and mechanism

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 Enrollment3,679

FDA Designations

No designations recorded

Amlodipine- reference clinical trials

Amlodipine- reference · 5 trials · 4 indications

Phase 3 5
NCT00530946A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And AtorvastatinHypertension
COMPLETED165 Analytics
NCT00443456Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is InsufficientHypertension
COMPLETED134 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
Hypertension
NCT00530946165
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PHASE3COMPLETED
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Hypertension
NCT00443456134
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PHASE3COMPLETED
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
Hypertension
NCT00415623305
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PHASE3COMPLETED
Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia
Hypertension
NCT003307851,250
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PHASE3COMPLETED
Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels
Hypertension
NCT001432341,825
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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 From Baseline of the Preceding Study
Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)

Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)

Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)

Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg

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)

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 -
SingleEXPERIMENTAL -
Amlodipine 5mgACTIVE_COMPARATOR -
Amlodipine 10mgEXPERIMENTAL -

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
AmlodipineDRUGTwo tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
Amlodipine/AtorvastatinDRUG -
Amlodipine/atorvastatin single pillDRUG -
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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 Emirates
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Competitive Landscape -Hypertension 72 trials

Top 9 of 16 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN5PHASE3Baxdrostat
Eli Lilly and CompanyLLY4PHASE3Orforglipron, Clazakizumab
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran, ALN-AGT01 RVR
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS3PHASE2QCZ484, HJB647
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
CRISPR Therapeutics AGCRSP1PHASE1CTX340
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Frequently asked questions about Amlodipine- reference

What is Amlodipine used for?

Amlodipine is used for the treatment of hypertension. It is also studied in fixed combination with atorvastatin for patients with hypertension and hypercholesterolemia or dyslipidemia. The clinical program includes five trials, with a total enrollment of 3,679 participants.

Who makes Amlodipine?

Amlodipine is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical trials referenced for this drug, including studies of amlodipine alone and in combination with atorvastatin.

What phase is Amlodipine in?

Amlodipine is in Phase 3 clinical development. The program includes five trials, of which one is completed and the remainder are also completed. The trials are randomized, double-blind, and active-controlled, with a total enrollment of 3,679 participants.

What clinical trials is Amlodipine in?

Amlodipine has been studied in several Phase 3 trials, including NCT00530946, which evaluated a fixed combination of amlodipine and atorvastatin; NCT00443456, a long-term study of amlodipine 10 mg; NCT00415623, comparing amlodipine 10 mg and 5 mg; and NCT00330785, an open-label study of amlodipine/atorvastatin.

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