A Phase 3 Study to Evaluate and Compare the Efficacy and Safety of AZM and AML Combined and Alone in Mild-to-moderate Essential Hypertensive Subjects

Sponsor

Celltrion (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05385770

Collaborator

(none)

852

Enrollment

Arms

14.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is an 8-week, randomized, double-blind Phase 3, multicentre study to determine the optimal dose of AZM and AML in combination therapy and to compare efficacy and tolerability of the combined therapy to each of the monotherapy in essential hypertensive subjects who are not adequately controlled on AZM and AML monotherapy.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: AZM X mg + AML Y mg Drug: AZM X mg + AML Y' mg Drug: AZM X' mg + AML Y mg Drug: AZM X' mg + AML Y' mg Drug: AZM X mg Drug: AZM X' mg Drug: AML Y mg Drug: AML Y' mg	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

852 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Single-blind Run-in period, Double-blind Treatment period

Primary Purpose:

Treatment

Official Title:

A Multicentre, Randomized, Double-blind Study to Evaluate and Compare the Efficacy and Safety of 8-week Treatment With AZM and AML Combined and Alone in Mild-to-moderate Essential Hypertensive Subjects

Anticipated Study Start Date :

May 31, 2022

Anticipated Primary Completion Date :

Jul 4, 2023

Anticipated Study Completion Date :

Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AZM Xmg 1. AZM Xmg (4 weeks) Non-responder -> AZM Xmg (8 weeks)	Drug: AZM X mg tablet, single dose, QD, oral administration
Active Comparator: AZM X'mg 1. AZM X'mg (4 weeks) Non-responder -> AZM X'mg (8 weeks)	Drug: AZM X' mg tablet, single dose, QD, oral administration
Active Comparator: AML Ymg 1. AML Ymg (4 weeks) Non-responder -> AML Ymg (8 weeks)	Drug: AML Y mg tablet, single dose, QD, oral administration
Active Comparator: AML Y'mg 1. AML Y'mg (4 weeks) Non-responder -> AML Y'mg (8 weeks)	Drug: AML Y' mg tablet, single dose, QD, oral administration
Active Comparator: AZM/AML X/Ymg AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks) AML Ymg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)	Drug: AZM X mg + AML Y mg tablet, single dose, QD, oral administration Drug: AZM X mg tablet, single dose, QD, oral administration Drug: AML Y mg tablet, single dose, QD, oral administration
Active Comparator: AZM/AML X'/Ymg AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks) AML Ymg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)	Drug: AZM X' mg + AML Y mg tablet, single dose, QD, oral administration Drug: AZM X' mg tablet, single dose, QD, oral administration Drug: AML Y mg tablet, single dose, QD, oral administration
Active Comparator: AZM/AML X/Y'mg AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks) AML Y'mg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)	Drug: AZM X mg + AML Y' mg tablet, single dose, QD, oral administration Drug: AZM X mg tablet, single dose, QD, oral administration Drug: AML Y' mg tablet, single dose, QD, oral administration
Active Comparator: AZM/AML X'/Y'mg AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks) AML Y'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)	Drug: AZM X' mg + AML Y' mg tablet, single dose, QD, oral administration Drug: AZM X' mg tablet, single dose, QD, oral administration Drug: AML Y' mg tablet, single dose, QD, oral administration

Outcome Measures

Primary Outcome Measures

msitSBP [after 8 weeks of treatment]
msitSBP change from baseline

Secondary Outcome Measures

msitDBP [after 8 weeks of treatment]
msitDBP change from baseline
msitSBP [after 4 weeks of treatment]
msitSBP change from baseline
msitDBP [after 4 weeks of treatment]
msitDBP change from baseline
Proportion of subjects achieving msitSBP < 140 mmHg and/or ΔmsitSBP ≥ 20 mmHg [after 4, 8 weeks of treatment]
Proportion of subjects achieving msitDBP < 90 mmHg and/or ΔmsitDBP ≥ 10 mmHg [after 4, 8 weeks of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects voluntarily agree to participate in the trial and signed the written ICF, after listening to the purpose, method, and effect of clinical trial
Male or female adult subjects (Legal minimum age of adult requirement is country specific, and requirement of current country specific regulations will be applied) below the age of 75 years, inclusive
Subjects with mild-to-moderate essential hypertension
Subjects who are capable of understanding and complying with protocol requirements

Exclusion Criteria:

Subjects who have msitSBP >180 mmHg or msitDBP >110 mmHg; Subjects who have difference in the blood pressure between 3 measurements (confirmed by a second set of three measurements; 3 sitting systolic BP (sitSBP) measurements differing by more than 20 mmHg or 3 sitting diastolic BP (sitDBP) measurements differing by more than 10 mmHg)
Secondary hypertension, Symptomatic orthostatic hypotension
Clinically significant Electrocardiogram (ECG) abnormalities, Severe heart disease, Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia, Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Severe cerebrovascular disease, Known moderate or malignant retinopathy within the past 6 months; History of unexplained syncope within the prior 2 years, or a known syncopal disorder
Significant thyroid disease, Type 1 or 2 diabetes mellitus with poor glucose control, Wasting disease, Autoimmune diseases, Connective tissue disease
Subjects who have clinically significant laboratory abnormalities : creatinine clearance < 30 mL/min, serum creatinine > 2 mg/dL or > 200 μmol/L, serum potassium <3.5 mmol/L or > 5.5mmol/L, alanine aminotransferase or aspartate aminotransferase > 3 × upper limit normal (ULN)
Any surgical or medical condition of the gastrointestinal tract that might significantly alter the absorption, distribution, metabolism, or excretion of the drug
Positive for HIV, HCV Ab, and/or HBsAg
History of drug or alcohol abuse within the past 1 year
Subjects who are pregnant or lactating women, women suspected of being pregnant, women who wish to be pregnant during the study, or women of child-bearing potential who are not using medically acceptable methods of contraception
Any chronic inflammatory condition needing chronic anti-inflammatory therapy, A known hypersensitivity to any main excipients and components of the investigational drugs or other drugs in the same class, Subjects who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-converting enzyme inhibitors or angiotensin II subtype 1 receptor blocker
Subjects who have received any investigational product within 90 days prior to screening or is currently participating in another investigational study
Subjects who are required to take excluded medications at any point during the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Celltrion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celltrion

ClinicalTrials.gov Identifier:

NCT05385770

Other Study ID Numbers:

CT-L05-301

First Posted:

May 23, 2022

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Essential Hypertension

Study Results

No Results Posted as of May 31, 2022