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Norvasc

Phase 3

Essential Hypertension | Small molecule | Cardiovascular |Tango Therapeutics, Inc.|Last Updated: Jun 5, 2025

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Norvasc · 1 trial · 1 indication

Phase 3 1
NCT05288400Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension.Essential Hypertension
COMPLETED150 Analytics
PHASE3COMPLETED
Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension.
Essential HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline of blood pressure (SBP and DBP)
at baseline, 4, 8 and 12 weeks

Secondary Endpoints

Blood pressure control rate (SBP < 140 mmHg and DBP < 90 mmHg)
at 4, 8 and 12 weeks
Response rate for antihypertensive therapy
at 4, 8 and 12 weeks
Assessment of patient treatment satisfaction TSQM-9 questionnaire
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALsingle-capsule of fixed dosed combination (FDC) of amlodipine 5 mg / bisoprolol fumarate 5 mg / perindopril arginine 5 mg
Group BACTIVE_COMPARATORFree triple therapy of amlodipine 5 mg + bisoprolol fumarate 5 mg + perindopril arginine 5 mg, given concomitantly

Interventions

NameTypeDescription
Amlodipine 5mg + bisoprolol fumarate 5mg + perindopril arginine 5mgCOMBINATION_PRODUCT1 capsule/day Oral administration
Norvasc 5mg tabletDRUGNorvasc (amlodipine) 5mg, 1 tablet/day
Concor 5mg tabletDRUGConcor (bisoprolol fumarate) 5mg, 1 tablet/day
Coversyl 5mg tabletDRUGCoversyl (perindopril arginine) 5mg, 1 tablet/day
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites15

Selection criteria: * Men or women of any ethnic origin ≥18 years old who signed Informed consent form. * Patients with uncontrolled hypertension defined by SBP ≥140 and \< 160 mmHg and DBP ≥90 and \< 100 mmHg already treated by anti-hypertensive monotherapy at maximal dose or either by a dual ther...

Countries:Russia
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Frequently asked questions about Norvasc

What is Norvasc used for?

Norvasc is used for the treatment of essential hypertension, a condition of persistently high blood pressure with no identifiable secondary cause. It is a small molecule cardiovascular therapy being developed as a fixed-dose combination in capsule form for patients whose blood pressure is not adequately controlled.

Who makes Norvasc?

Norvasc is being developed by Tango Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker TNGX. The company is conducting clinical research on this drug for the treatment of essential hypertension.

What phase is Norvasc in?

Norvasc is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under clinical investigation for essential hypertension.

What clinical trials is Norvasc in?

Norvasc has one completed Phase 3 clinical trial registered under NCT05288400. This trial evaluated the efficacy and safety of a fixed-dose combination of amlodipine 5mg, bisoprolol fumarate 5mg, and perindopril arginine 5mg compared to free monotherapy in patients with uncontrolled essential hypertension.

Is Norvasc the same as amlodipine?

Norvasc is a fixed-dose combination that includes amlodipine 5mg, bisoprolol fumarate 5mg, and perindopril arginine 5mg. It is not the same as amlodipine alone, as it combines three active ingredients in a single capsule for the treatment of essential hypertension.

How does Norvasc work?

Norvasc combines three antihypertensive agents: amlodipine, a calcium channel blocker; bisoprolol, a beta-blocker; and perindopril, an ACE inhibitor. These agents work through complementary mechanisms to lower blood pressure in patients with essential hypertension.