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LCZ

Phase 3

Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Jan 13, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment718

FDA Designations

No designations recorded

Clinical trial landscape

LCZ · 1 trial · 1 indication

Phase 3 1
NCT06236061Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 MonotherapyHypertension
COMPLETED718 Analytics
PHASE3COMPLETED
Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

[Core Part] Change from baseline to Week 8 in msSBP
Baseline, Week 8

Change from baseline to Week 8 in mean sitting systolic blood pressure (msSBP)

Secondary Endpoints

[Core Part] Change from baseline to Week 8 in maSBP
Baseline, Week 8
[Core Part] Proportion of patients achieving a blood pressure control after 8 weeks of treatment
8 weeks
[Core Part] Change from baseline to Week 8 in msDBP
Baseline, Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LCZ 200mgACTIVE_COMPARATOROral administration, 1 tablet of LCZ 200 mg daily, 4 capsules of Amlodipine placebo daily.
LCZ 200mg + AML 2.5mgEXPERIMENTALOral administration, 1 tablet of LCZ 200 mg daily, 1 capsule of Amlodipine 2.5 mg daily and 3 capsules of Amlodipine placebo daily.
LCZ 200mg + AML 5mgEXPERIMENTALOral administration, 1 tablet of LCZ 200 mg daily, 2 capsules of Amlodipine 2.5 mg daily and 2 capsules of Amlodipine placebo daily.
LCZ 200mg + AML 10mgEXPERIMENTALOral administration, 1 tablet of LCZ 200 mg daily, 4 capsules of Amlodipine 2.5 mg daily.

Interventions

NameTypeDescription
LCZDRUGLCZ 200 mg
LCZ/AML 200 mg/2.5 mgDRUGLCZ/AML 200 mg/2.5 mg
LCZ/AML 200 mg/5 mgDRUGLCZ/AML 200 mg/5 mg
LCZ/AML 200 mg/10 mgDRUGLCZ/AML 200 mg/10 mg
PlaceboOTHERMatching placebo of Amlodipine.
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: Core Part) * Patients with grade 1 and 2 essential hypertension, untreated or currently taking antihypertensive therapy 1. Untreated patients \[either newly diagnosed with essential hypertension or those with a history of hypertension but have not been taking any antihyperte...

Countries:Japan
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Frequently asked questions about LCZ

What is LCZ used for?

LCZ is an investigational small molecule being developed for the treatment of hypertension. It is currently in Phase 3 clinical development, though the specific trial for LCZ has been completed. The drug is being studied in patients with Grade 1 and 2 hypertension who are uncontrolled by LCZ696 monotherapy.

Who makes LCZ?

LCZ is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical research on LCZ for the treatment of hypertension, with the drug currently in Phase 3 development.

What phase is LCZ in?

LCZ is in Phase 3 clinical development for hypertension. The Phase 3 trial, NCT06236061, has been completed. This trial enrolled 718 participants and was a randomized, double-blind, active-controlled study conducted in Japan. LCZ remains investigational and has not been approved by regulatory authorities.

What clinical trials is LCZ in?

LCZ has one completed Phase 3 clinical trial, registered as NCT06236061. The study evaluated the efficacy and safety of LCZ696/Amlodipine in patients with Grade 1 and 2 hypertension uncontrolled by LCZ696 monotherapy. The trial enrolled 718 participants in Japan and was randomized, double-blind, and active-controlled.

Is LCZ the same as LCZ696?

LCZ is being studied in combination with LCZ696, as the trial evaluates LCZ696/Amlodipine. The drug name LCZ appears to refer to the combination product or a component of it. The completed Phase 3 trial specifically tested LCZ696/Amlodipine in hypertension patients uncontrolled by LCZ696 monotherapy.