Assess Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine

NCT07704684 | Completed Phase 3

• 1 other identifier: SAL0130A301
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study will be to assess the efficacy and safety of Sacubitril/Allisartan (240mg) and Amlodipine (5mg) in patients with essential hypertension uncontrolled after 4-week treatment with Amlodipine (5mg).

Conditions

Essential Hypertension

Keywords

Hypertension; Sacubitril; Allisartan; Amlodipine

Outcome Measures

Primary Outcomes (1)

• The baseline change in mean seated systolic blood pressure (msSBP)

  Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment

  at 12 weeks

Study Arms (2)

Test Group

EXPERIMENTAL

Drug: Experimental: Sacubitril/Allisartan and Amlodipine Group

Reference Group

ACTIVE COMPARATOR

Drug: Active Comparator: Amlodipine Group

Interventions

Experimental: Sacubitril/Allisartan and Amlodipine Group DRUG

Drug: Sacubitril/Allisartan and Amlodipine

Test Group

Active Comparator: Amlodipine Group DRUG

Drug: Amlodipine

Reference Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-75 years old.
• Confirmed diagnosis of essential hypertension.
• Patients who meet one of the following criteria when screening:
• A. Treatment-naive patients (newly diagnosed essential hypertension, or patients with a prior hypertension history who have not taken any antihypertensive medication for at least 4 weeks prior to screening): mean seated systolic blood pressure (msSBP) ≥150 mmHg and \<180 mmHg.
• B. Patients with irregular oral administration of amlodipine besylate (5 mg once daily) (treatment duration less than 4 weeks before screening, or more than 5 missed dosing days within the 4 weeks prior to screening): msSBP ≥140 mmHg and\<180 mmHg.
• C. Patients on existing stable antihypertensive therapy (receiving a stable dose of another single-agent antihypertensive, free combination of two single-agent drugs, or single-pill fixed-dose combination containing two active ingredients for at least 4 weeks prior to screening): msSBP ≥140 mmHg and \<180 mmHg, and the physician determines that switching treatment to amlodipine besylate (5 mg once daily) is clinically appropriate.
• D. Patients with essential hypertension who have been regularly treated with amlodipine besylate (5mg once daily) for ≥4 weeks and have msSBP ≥140 mmHg and\<180 mmHg. The previously regularly administered product shall be Norvasc® or generic amlodipine besylate that has passed the generic consistency evaluation in China.
• At randomization, subjects must have msSBP ≥140 mmHg and \<180 mmHg.
• Subjects voluntarily participate in the trial and sign the written informed consent form.

You may not qualify if:

• Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg).
• History or confirmed diagnosis of secondary hypertension.
• Concomitant use of three or more types of antihypertensive agents.
• Personal history of angioedema induced by drugs or other causes.
• Clinically significant abnormal laboratory findings, including but not limited to: serum potassium \>5.5 mmol/L or \<3.5 mmol/L; serum ALT and/or AST \>2.5 × upper limit of normal (ULN); serum creatinine \>1.5 × ULN; any other clinically significant laboratory abnormality deemed by the investigator likely to confound efficacy and/or safety assessment of the study.
• Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus .
• Subjects with active malignant tumor.
• History of substance abuse or excessive alcohol consumption within 6 months prior to screening.
• Blood donation or major blood loss (\>400 mL) within 3 months prior to screening, or clinically diagnosed hypovolemia.
• Participation in any interventional clinical trial with investigational medicinal product or medical device within 3 months prior to screening.
• Drug compliance during run-in period \<80% or \>120%.
• Any other conditions deemed inappropriate for trial enrollment by the investigator that may interfere with efficacy and/or safety evaluation of the study, including but not limited to anticipated poor subject compliance or impractical regular follow-up due to long residential distance.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: June 28, 2023
• Primary Completion: August 26, 2025
• Study Completion: September 8, 2025
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CN (1)