CompletedPhase 3

Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy

Japan718 participantsStarted 2024-04-08

Plain-language summary

This CLAZ696B11302 study is composed of two parts; the Core part including double-blind period, and the open-label extension (OLE) part which is an open-label extension of the Core part. The purpose of the Core part is to demonstrate that LCZ696 (LCZ) when used in combination with amlodipine (AML), denoted as LCZ/AML, will provide greater blood pressure lowering benefit compared to LCZ monotherapy in patients with grade 1 and 2 hypertension not adequately controlled with LCZ monotherapy. The purpose of the OLE part is to assess the long-term safety, tolerability and efficacy of the treatment with LCZ/AML.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Untreated patients \[either newly diagnosed with essential hypertension or those with a history of hypertension but have not been taking any antihypertensive drugs for 4 weeks prior to screening visit (Visit Scr)\] must have a msSBP of ≥ 150 mmHg and \< 180 mmHg at both screening (Visit Scr) and run-in visit (Visit Run-in)
✓. Pretreated patients (taking antihypertensive drugs within 4 weeks prior to screening visit (Visit Scr)) must have msSBP \< 180 mmHg at screening visit (Visit Scr), and msSBP ≥ 150 mmHg and \< 180 mmHg at run-in visit (Visit Run-in)

What they're measuring

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

Timeframe: Baseline, Week 8

Trial details

NCT IDNCT06236061

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-28

View on ClinicalTrials.gov More Hypertension trials