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Amlodipine

Phase 4FDA approved

Hypertension | Small molecule | Cardiovascular |Pfizer, Inc.|Trials Updated: Oct 28, 2009

Amlodipine development status

FDA approval on record Oct 31, 2003
Approval holderDr Reddys Labs Inc
ApplicationNDA021435
Highest phase Phase 4 run by Novartis (NCT00853957)
Phase scored for PFEPhase 3
Registered trials 58 across 17 sponsors since Jun 2002

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment134

FDA Designations

No designations recorded

Amlodipine clinical trials

Amlodipine · 1 trial · 1 indication

Phase 3 1
NCT00443456Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is InsufficientHypertension
COMPLETED134 Analytics
PHASE3COMPLETED
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Hypertension
NCT00443456134
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Study Endpoints

Primary Endpoints

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

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SingleEXPERIMENTAL -

Interventions

NameTypeDescription
AmlodipineDRUGTwo tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
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Eligibility Criteria

Age Range20 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety * Patients who had a treatment compliance rate of at least 80% Exclusion Criteria:...

Countries:Japan
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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

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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