HypertensionPhase 3NCT06236061
Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy
A Phase 3 study testing LCZ, LCZ/AML 200 mg/2.5 mg and LCZ/AML 200 mg/5 mg in people with Hypertension, run by Novartis Pharmaceuticals at 43 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension
- What is being tested?
- LCZ, LCZ/AML 200 mg/2.5 mg and LCZ/AML 200 mg/5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 718 participants
- Where
- 43 sitesJapan
- Study dates
- 8 Apr 2024to 23 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Core Part)
- Patients with grade 1 and 2 essential hypertension, untreated or currently taking antihypertensive therapy
- 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)
- Patients who are not adequately responsive to LCZ 200 mg treatment must have a msSBP ≥ 140 mmHg and < 180 mmHg at the end of run-in/randomization visit
- Patients who are able to communicate well with the Investigator, to understand and comply with all study requirements, and demonstrate good medication compliance (≥ 80% compliance rate) during the single-blind run-in period OLE part)
- Patients who have completed the Core part without permanent study drug discontinuation and who, as judged by the Investigator, are able to continue in the OLE part
- Patients who have msSBP < 160 mmHg and msDBP <100 mmHg at Visit W8 of the double-blind period
Who cannot join
- Core part)
- Patients currently on one or more antihypertensive medications in whom the Investigator considers that the medications cannot be safely discontinued for the duration of the Core part
- Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg at any visit prior to or at randomization), or malignant hypertension
- History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, sleep apnea, and drug-induced hypertension
- Patients with Type 1 or Type 2 diabetes mellitus not well controlled based on the Investigator's clinical judgement
- Concomitant refractory angina pectoris [angina in setting of Coronary Artery Disease (CAD) which is uncontrolled by combination of optimal medical therapy, angioplasty or bypass surgery]
Show all 15Show fewer
- Clinically significant valvular heart disease at screening
- Any history of stroke or hypertensive encephalopathy
- History of hypersensitivity to any of the study treatments or its excipients, ARBs or to drugs of similar chemical classes
- Use of other investigational drugs within 30 days or 5 half-lives of screening visit, whichever is longer OLE part)
- Any medical condition that in the opinion of the Investigator is likely to prevent the patient from safely tolerating LCZ/AML or complying with the requirements of the study
- Patients who have experience of angioedema event(s) which occurred and reported by the Investigator during the Core part of study
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 10 days after stopping study treatment. Highly effective contraception methods are defined as same as the criteria for the Core part.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Japan43 sites
Novartis Investigative Site
Akashi, Hyōgo, 674-0081
Novartis Investigative Site
Amagasaki, Hyōgo, 660-0861
Novartis Investigative Site
Chitose, Hokkaido, 066-0032
Novartis Investigative Site
Chiyoda City, Tokyo, 101-0041
Novartis Investigative Site
Chuo Ku, Tokyo, 104-0031
Novartis Investigative Site
Chuo-ku, Tokyo, 1030027
Novartis Investigative Site
Chuoh-ku, 104-0031
Novartis Investigative Site
Fukuoka, 810-0021
Novartis Investigative Site
Hachiōji, Tokyo, 192-0046
Novartis Investigative Site
Hiroshima, 732-0053
Novartis Investigative Site
Itoshima, Fukuoka, 8191104
Novartis Investigative Site
Kamakura, Kanagawa, 247-0055
Novartis Investigative Site
Kawasaki-shi, Kanagawa, 211-0041
Novartis Investigative Site
Kiyose, Tokyo, 204-0021
Novartis Investigative Site
Kyoto, 615-8125
Novartis Investigative Site
Musashino, Tokyo, 1800022
Novartis Investigative Site
Nagoya, Aichi-ken, 4518511
Novartis Investigative Site
Nagoya, Aichi-ken, 453-0804
Novartis Investigative Site
Nagoya, Aichi-ken, 4540933
Novartis Investigative Site
Nagoya, Aichi-ken, 4578511
Novartis Investigative Site
Nerima Ku, Tokyo, 1770051
Novartis Investigative Site
Osaka, 5300002
Novartis Investigative Site
Osaka, 5320003
Novartis Investigative Site
Osaka, 536-0008
Novartis Investigative Site
Osaka, 550-0013
Novartis Investigative Site
Ōsaki, Miyagi, 989-6143
Novartis Investigative Site
Sapporo, Hokkaido, 30026
Novartis Investigative Site
Sapporo, Hokkaido, 630826
Novartis Investigative Site
Sapporo, Hokkaido, 630842
Novartis Investigative Site
Sendai, Miyagi, 980-0011
Novartis Investigative Site
Sendai, Miyagi, 9830039
Novartis Investigative Site
Setagaya-ku, Tokyo, 1550031
Novartis Investigative Site
Shibuya City, Tokyo, 150-0013
Novartis Investigative Site
Shinagawa-Ku, Tokyo, 141-0032
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0008
Novartis Investigative Site
Shinjuku-ku, Tokyo, 1600017
Novartis Investigative Site
Shinjuku-ku, Tokyo, 1690072
Novartis Investigative Site
Suginami-ku, Tokyo, 166-0003
Novartis Investigative Site
Suita, Osaka, 5650853
Novartis Investigative Site
Toshima-Ku, Tokyo, 171-0021
Novartis Investigative Site
Tsukuba, Ibaraki, 3050861
Novartis Investigative Site
Yokohama, Kanagawa, 231-0023
Novartis Investigative Site
Yokohama, Kanagawa, 232-0064
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696/Amlodipine 200/2.5 mg, 200/5 mg and 200/10 mg Compared to LCZ696 200 mg Alone in Patients With Grade 1 and 2 Hypertension Not Adequately Controlled by LCZ696 200 mg Monotherapy
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.
Read the detailed description
This study is designed to provide efficacy and safety data for combinations of LCZ 200 mg and AML (2.5 mg, 5 mg or 10 mg) as compared to LCZ monotherapy in patients with grade 1 and 2 hypertension not adequately controlled with LCZ monotherapy, and also the long-term safety, tolerability and efficacy of the treatment with LCZ/AML. The Core part is a multicenter, randomized, double-blind, parallel-group, active-controlled study which is comprised of the following three periods: Screening / washout period, Single-blind active run-in period, Double-blind treatment period (8 weeks). A 52 week, open-label extension part will be conducted following the completion of the Core part. Those participants that complete the Core part without permanent study drug discontinuation will be offered continued participation in an additional 1 year safety extension to the protocol. Of the patients completed the Core part, approximately 278 participants who are eligible and agree to participate and sign a new informed consent form will start the OLE part, and receive the open-label LCZ/AML combination drug through the OLE part. At start of the OLE part, all participants will be switched to the open-label LCZ/AML 200 mg/5 mg combination drug from double-blinded study medication. After 4 weeks of OLE part, the dosage will be titrated up to LCZ/AML 200 mg/10 mg if an adequate control in blood pressure is not achieved [msSBP ≥ 130 mmHg or msDBP ≥ 80 mmHg, or the Investigator's judgement basically in accordance with the current local hypertension treatment guideline (JSH2019)] and when there is no safety concern on up-titration judged by the Investigator. If the blood pressure is controlled optimally, the participants will continue to receive LCZ/AML 200 mg/5 mg. Down-titration from LCZ/AML 200 mg/5 mg to LCZ/AML 200 mg/2.5 mg is permitted after the start of OLE part if participants are having difficulty with the current treatment of LCZ/AML 200 mg/5 mg due to adverse events (AEs) etc. Dose adjustment (up or down-titration) is allowed if participants meet the criteria for dose adjustment (the same defined above as up-titration and down-titration). The Investigators should maintain the maximum tolerated dose as much as possible after 8 weeks of OLE part. Thiazide diuretics/thiazide-like diuretics are allowed as rescue medication(s) at the investigator's discretion on and after 8 weeks of OLE part, if blood pressure is not adequately controlled even with LCZ/AML 200 mg/10 mg or maximum tolerated dose and with no signs of hypovolemia. Initial dose of the concomitant diuretics should be low, then the dose can be adjusted.
- Conditions
- Hypertension
- Being tested
- LCZ, LCZ/AML 200 mg/2.5 mg, LCZ/AML 200 mg/5 mg, LCZ/AML 200 mg/10 mg, Placebo
- Keywords
- LCZ696, Phase 3, grade 1 and 2 hypertension, Amlodipine
- Medical subject headings
- Hypertension, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZDrug
Also called LCZ696
LCZ 200 mg
LCZ/AML 200 mg/2.5 mgDrug
Also called LCZ696/Amlodipine
LCZ/AML 200 mg/2.5 mg
LCZ/AML 200 mg/5 mgDrug
Also called LCZ696/Amlodipine
LCZ/AML 200 mg/5 mg
LCZ/AML 200 mg/10 mgDrug
Also called LCZ696/Amlodipine
LCZ/AML 200 mg/10 mg
PlaceboOther
Matching placebo of Amlodipine.
| Study group | Role | What they receive |
|---|---|---|
| LCZ 200mg | Active comparator | Oral administration, 1 tablet of LCZ 200 mg daily, 4 capsules of Amlodipine placebo daily. Receives: Drug: LCZ; Other: Placebo |
| LCZ 200mg + AML 2.5mg | Experimental | Oral administration, 1 tablet of LCZ 200 mg daily, 1 capsule of Amlodipine 2.5 mg daily and 3 capsules of Amlodipine placebo daily. Receives: Drug: LCZ/AML 200 mg/2.5 mg; Other: Placebo |
| LCZ 200mg + AML 5mg | Experimental | Oral administration, 1 tablet of LCZ 200 mg daily, 2 capsules of Amlodipine 2.5 mg daily and 2 capsules of Amlodipine placebo daily. Receives: Drug: LCZ/AML 200 mg/5 mg; Other: Placebo |
| LCZ 200mg + AML 10mg | Experimental | Oral administration, 1 tablet of LCZ 200 mg daily, 4 capsules of Amlodipine 2.5 mg daily. Receives: Drug: LCZ/AML 200 mg/10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Core Part] Change from baseline to Week 8 in msSBP
Change from baseline to Week 8 in mean sitting systolic blood pressure (msSBP)
Measured: Baseline, Week 8
Secondary outcomes (12)
[Core Part] Change from baseline to Week 8 in maSBP
Change from baseline to Week 8 in mean 24-hour ambulatory systolic blood pressure (maSBP)
Measured: Baseline, Week 8
[Core Part] Proportion of patients achieving a blood pressure control after 8 weeks of treatment
Proportion of patients achieving a blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) after 8 weeks of treatment
Measured: 8 weeks
[Core Part] Change from baseline to Week 8 in msDBP
Change from baseline to Week 8 in mean sitting diastolic blood pressure (msDBP)
Measured: Baseline, Week 8
[Core Part] Change from baseline to Week 8 in maDBP
Change from baseline to Week 8 in mean 24-hour ambulatory diastolic blood pressure (maDBP)
Measured: Baseline, Week 8
[Core Part] Proportion of patients achieving a msSBP response after 8 weeks of treatment
Proportion of patients achieving a msSBP response (<140 mmHg or a reduction ≥20 mmHg from baseline) after 8 weeks of treatment
Measured: 8 weeks
[Core Part] Proportion of patients achieving a msDBP response after 8 weeks of treatment
Proportion of patients achieving a msDBP response (<90 mmHg or a reduction ≥10 mmHg from baseline) after 8 weeks of treatment
Measured: 8 weeks
[Core Part] Change from baseline to Week 8 in daytime, nighttime and early morning maSBP
Change from baseline to Week 8 in daytime, nighttime and early morning maSBP
Measured: Baseline, Week 8
[Core Part] Change from baseline to Week 8 in daytime, nighttime and early morning maDBP
Change from baseline to Week 8 in daytime, nighttime and early morning maDBP
Measured: Baseline, Week 8
[Core Part] Number of patients with treatment-emergent adverse events
Number of patients experiencing treatment-emergent adverse events including (but not limited to) any unfavorable and unintended signs, symptoms or disease, abnormal vital signs, electrocardiogram data, safety lab measurements that induce clinical signs or symptoms, are considered clinically significant or require therapy
Measured: Up to 8 weeks
[OLE Part] Number of patients with treatment-emergent adverse events
Number of patients experiencing treatment-emergent adverse events including (but not limited to) any unfavorable and unintended signs, symptoms or disease, abnormal vital signs, electrocardiogram data, safety lab measurements that induce clinical signs or symptoms, are considered clinically significant or require therapy
Measured: Up to 52 weeks
[OLE Part] Change from baseline in msSBP and msDBP
Change from baseline in msSBP and msDBP by visit in OLE part
Measured: Baseline, Week 4, Week 8, Week 13, Week 26, Week 39, and Week 52 of OLE part
[OLE Part] Proportion of patients achieving blood pressure control, msSBP response and msDBP response
Proportion of patients achieving blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg), msSBP response (<140 mmHg or a reduction ≥20 mmHg from baseline) and msDBP response (<90 mmHg or a reduction ≥10 mmHg from baseline) by visit
Measured: Over 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start8 Apr 2024
- Primary completion28 May 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is composed of two parts; the Core part including double-blind period, and the open-label extension (OLE) part. The Core part is a parallel model, and the OLE is a sequential model.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236061
- Sponsor's protocol ID
- CLAZ696B11302
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696/Amlodipine 200/2.5 mg, 200/5 mg and 200/10 mg Compared to LCZ696 200 mg Alone in Patients With Grade 1 and 2 Hypertension Not Adequately Controlled by LCZ696 200 mg Monotherapy
- ClinicalTrials.gov ID
- NCT06236061
- Acronym / sponsor ID
- CLAZ696B11302
- Conditions
- Hypertension
- Keywords
- LCZ696, Phase 3, grade 1 and 2 hypertension, Amlodipine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to provide efficacy and safety data for combinations of LCZ 200 mg and AML (2.5 mg, 5 mg or 10 mg) as compared to LCZ monotherapy in patients with grade 1 and 2 hypertension not adequately controlled with LCZ monotherapy, and also the long-term safety, tolerability and efficacy of the treatment with LCZ/AML. The Core part is a multicenter, randomized, double-blind, parallel-group, active-controlled study which is comprised of the following three periods: Screening / washout period, Single-blind active run-in period, Double-blind treatment period (8 weeks). A 52 week, open-label extension part will be conducted following the completion of the Core part. Those participants that complete the Core part without permanent study drug discontinuation will be offered continued participation in an additional 1 year safety extension to the protocol. Of the patients completed the Core part, approximately 278 participants who are eligible and agree to participate and sign a new informed consent form will start the OLE part, and receive the open-label LCZ/AML combination drug through the OLE part. At start of the OLE part, all participants will be switched to the open-label LCZ/AML 200 mg/5 mg combination drug from double-blinded study medication. After 4 weeks of OLE part, the dosage will be titrated up to LCZ/AML 200 mg/10 mg if an adequate control in blood pressure is not achieved [msSBP ≥ 130 mmHg or msDBP ≥ 80 mmHg, or the Investigator's judgement basically in accordance with the current local hypertension treatment guideline (JSH2019)] and when there is no safety concern on up-titration judged by the Investigator. If the blood pressure is controlled optimally, the participants will continue to receive LCZ/AML 200 mg/5 mg. Down-titration from LCZ/AML 200 mg/5 mg to LCZ/AML 200 mg/2.5 mg is permitted after the start of OLE part if participants are having difficulty with the current treatment of LCZ/AML 200 mg/5 mg due to adverse events (AEs) etc. Dose adjustment (up or down-titration) is allowed if participants meet the criteria for dose adjustment (the same defined above as up-titration and down-titration). The Investigators should maintain the maximum tolerated dose as much as possible after 8 weeks of OLE part. Thiazide diuretics/thiazide-like diuretics are allowed as rescue medication(s) at the investigator's discretion on and after 8 weeks of OLE part, if blood pressure is not adequately controlled even with LCZ/AML 200 mg/10 mg or maximum tolerated dose and with no signs of hypovolemia. Initial dose of the concomitant diuretics should be low, then the dose can be adjusted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This study is composed of two parts; the Core part including double-blind period, and the open-label extension (OLE) part. The Core part is a parallel model, and the OLE is a sequential model.
| Arm | Type | Receives |
|---|---|---|
| LCZ 200mg | Active comparator | Drug: LCZ, Other: PlaceboOral administration, 1 tablet of LCZ 200 mg daily, 4 capsules of Amlodipine placebo daily. |
| LCZ 200mg + AML 2.5mg | Experimental | Drug: LCZ/AML 200 mg/2.5 mg, Other: PlaceboOral 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 5mg | Experimental | Drug: LCZ/AML 200 mg/5 mg, Other: PlaceboOral 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 10mg | Experimental | Drug: LCZ/AML 200 mg/10 mgOral administration, 1 tablet of LCZ 200 mg daily, 4 capsules of Amlodipine 2.5 mg daily. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Core Part)
- Patients with grade 1 and 2 essential hypertension, untreated or currently taking antihypertensive therapy
- Patients who are not adequately responsive to LCZ 200 mg treatment must have a msSBP ≥ 140 mmHg and < 180 mmHg at the end of run-in/randomization visit
- Patients who are able to communicate well with the Investigator, to understand and comply with all study requirements, and demonstrate good medication compliance (≥ 80% compliance rate) during the single-blind run-in period OLE part)
- Patients who have completed the Core part without permanent study drug discontinuation and who, as judged by the Investigator, are able to continue in the OLE part
Key exclusion criteria (15 listed)
- Core part)
- Patients currently on one or more antihypertensive medications in whom the Investigator considers that the medications cannot be safely discontinued for the duration of the Core part
- Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg at any visit prior to or at randomization), or malignant hypertension
- History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, sleep apnea, and drug-induced hypertension
- Patients with Type 1 or Type 2 diabetes mellitus not well controlled based on the Investigator's clinical judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCZAlso: LCZ696LCZ 200 mg | Drug | LCZ 200mg |
| LCZ/AML 200 mg/2.5 mgAlso: LCZ696/AmlodipineLCZ/AML 200 mg/2.5 mg | Drug | LCZ 200mg + AML 2.5mg |
| LCZ/AML 200 mg/5 mgAlso: LCZ696/AmlodipineLCZ/AML 200 mg/5 mg | Drug | LCZ 200mg + AML 5mg |
| LCZ/AML 200 mg/10 mgAlso: LCZ696/AmlodipineLCZ/AML 200 mg/10 mg | Drug | LCZ 200mg + AML 10mg |
| PlaceboMatching placebo of Amlodipine. | Other | LCZ 200mg, LCZ 200mg + AML 2.5mg, LCZ 200mg + AML 5mg |
Primary outcome
[Core Part] Change from baseline to Week 8 in msSBP
Time frame: Baseline, Week 8
Change from baseline to Week 8 in mean sitting systolic blood pressure (msSBP)
12 secondary outcomes
[Core Part] Change from baseline to Week 8 in maSBP
Time frame: Baseline, Week 8
[Core Part] Proportion of patients achieving a blood pressure control after 8 weeks of treatment
Time frame: 8 weeks
[Core Part] Change from baseline to Week 8 in msDBP
Time frame: Baseline, Week 8
[Core Part] Change from baseline to Week 8 in maDBP
Time frame: Baseline, Week 8
[Core Part] Proportion of patients achieving a msSBP response after 8 weeks of treatment
Time frame: 8 weeks
[Core Part] Proportion of patients achieving a msDBP response after 8 weeks of treatment
Time frame: 8 weeks
[Core Part] Change from baseline to Week 8 in daytime, nighttime and early morning maSBP
Time frame: Baseline, Week 8
[Core Part] Change from baseline to Week 8 in daytime, nighttime and early morning maDBP
Time frame: Baseline, Week 8
[Core Part] Number of patients with treatment-emergent adverse events
Time frame: Up to 8 weeks
[OLE Part] Number of patients with treatment-emergent adverse events
Time frame: Up to 52 weeks
[OLE Part] Change from baseline in msSBP and msDBP
Time frame: Baseline, Week 4, Week 8, Week 13, Week 26, Week 39, and Week 52 of OLE part
[OLE Part] Proportion of patients achieving blood pressure control, msSBP response and msDBP response
Time frame: Over 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LCZ, LCZ/AML 200 mg/2.5 mg and LCZ/AML 200 mg/5 mg in people with Hypertension, run by Novartis Pharmaceuticals at 43 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Core Part] Change from baseline to Week 8 in msSBP (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.