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New combo pill shows promise for stubborn high blood pressure

NCT ID NCT06236061

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding amlodipine to the blood pressure drug LCZ696 works better than LCZ696 alone. About 718 adults with mild-to-moderate high blood pressure that wasn't well controlled by LCZ696 took part. The goal was to see if the combination lowers blood pressure more effectively over 8 weeks, with a long-term follow-up for safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

718 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Core Part) * Patients with grade 1 and 2 essential hypertension, untreated or currently taking antihypertensive therapy 1. Untreated patients \[either newly diagnosed with essential hypertension or those with a history of hypertension but have not been taking any antihypertensive drugs for 4 weeks prior to screening visit (Visit Scr)\] must have a msSBP of ≥ 150 mmHg and \< 180 mmHg at both screening (Visit Scr) and run-in visit (Visit Run-in) 2. 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 Exclusion Criteria: 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 \[angina in setting of Coronary Artery Disease (CAD) which is uncontrolled by combination of optimal medical therapy, angioplasty or bypass surgery\] * 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.

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Conditions

The condition(s) this trial relates to.

essential hypertension follicular lymphoma hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension

Contacts and locations

Locations

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4518511, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 453-0804, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4540933, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578511, Japan

  • Novartis Investigative Site

    Itoshima, Fukuoka, 8191104, Japan

  • Novartis Investigative Site

    Chitose, Hokkaido, 066-0032, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 30026, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 630826, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 630842, Japan

  • Novartis Investigative Site

    Akashi, Hyōgo, 674-0081, Japan

  • Novartis Investigative Site

    Amagasaki, Hyōgo, 660-0861, Japan

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 3050861, Japan

  • Novartis Investigative Site

    Kamakura, Kanagawa, 247-0055, Japan

  • Novartis Investigative Site

    Kawasaki-shi, Kanagawa, 211-0041, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 231-0023, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232-0064, Japan

  • Novartis Investigative Site

    Ōsaki, Miyagi, 989-6143, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 980-0011, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 9830039, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650853, Japan

  • Novartis Investigative Site

    Chiyoda City, Tokyo, 101-0041, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-0031, Japan

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 1030027, Japan

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0046, Japan

  • Novartis Investigative Site

    Kiyose, Tokyo, 204-0021, Japan

  • Novartis Investigative Site

    Musashino, Tokyo, 1800022, Japan

  • Novartis Investigative Site

    Nerima Ku, Tokyo, 1770051, Japan

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 1550031, Japan

  • Novartis Investigative Site

    Shibuya City, Tokyo, 150-0013, Japan

  • Novartis Investigative Site

    Shinagawa-Ku, Tokyo, 141-0032, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 160-0008, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1600017, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1690072, Japan

  • Novartis Investigative Site

    Suginami-ku, Tokyo, 166-0003, Japan

  • Novartis Investigative Site

    Toshima-Ku, Tokyo, 171-0021, Japan

  • Novartis Investigative Site

    Chuoh-ku, 104-0031, Japan

  • Novartis Investigative Site

    Fukuoka, 810-0021, Japan

  • Novartis Investigative Site

    Hiroshima, 732-0053, Japan

  • Novartis Investigative Site

    Kyoto, 615-8125, Japan

  • Novartis Investigative Site

    Osaka, 5300002, Japan

  • Novartis Investigative Site

    Osaka, 5320003, Japan

  • Novartis Investigative Site

    Osaka, 536-0008, Japan

  • Novartis Investigative Site

    Osaka, 550-0013, Japan

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