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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05385770
• Other study ID #: CT-L05-301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 31, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 890
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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 28 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

Related Conditions & MeSH terms

• Essential Hypertension

Intervention

Drug:
• AZM X mg + AML Y mg
tablet, single dose, QD, oral administration
• AZM X mg + AML Y' mg
tablet, single dose, QD, oral administration
• AZM X' mg + AML Y mg
tablet, single dose, QD, oral administration
• AZM X' mg + AML Y' mg
tablet, single dose, QD, oral administration
• AZM X mg
tablet, single dose, QD, oral administration
• AZM X' mg
tablet, single dose, QD, oral administration
• AML Y mg
tablet, single dose, QD, oral administration
• AML Y' mg
tablet, single dose, QD, oral administration

Locations

Country	Name	City	State
Korea, Republic of	Celltrion	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	msitSBP	msitSBP change from baseline	after 8 weeks of treatment
Secondary	msitDBP	msitDBP change from baseline	after 8 weeks of treatment
Secondary	msitSBP	msitSBP change from baseline	after 4 weeks of treatment
Secondary	msitDBP	msitDBP change from baseline	after 4 weeks of treatment
Secondary	Proportion of subjects achieving msitSBP < 140 mmHg and/or ?msitSBP = 20 mmHg		after 4, 8 weeks of treatment
Secondary	Proportion of subjects achieving msitDBP < 90 mmHg and/or ?msitDBP = 10 mmHg		after 4, 8 weeks of treatment