A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxAsia)

A Double-Blind, Randomized, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

Study Overview

• Status: Not yet recruiting
• Conditions: Resistant Hypertension; Uncontrolled Hypertension
• Intervention / Treatment: Drug: Baxdrostat; Drug: Placebo

Detailed Description

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 Asian participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 140 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Argentina
  • Caba, Argentina, C1426
    • Research Site
• China
  • Baotou, China, 014010
    • Research Site
  • Beijing, China, 100029
    • Research Site
  • Beijing, China, 100044
    • Research Site
  • Bengbu, China, 233060
    • Research Site
  • Changde, China, 415003
    • Research Site
  • Changsha, China, 410015
    • Research Site
  • Changsha, China, 430033
    • Research Site
  • Changzhou, China, 272100
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Chongqing, China, 400010
    • Research Site
  • Chongqing, China, 400042
    • Research Site
  • Deyang, China, 618000
    • Research Site
  • Guangzhou, China, 510100
    • Research Site
  • Ha'er Bin, China, 150001
    • Research Site
  • Hangzhou, China, 310014
    • Research Site
  • Hefei, China, 230601
    • Research Site
  • Heze, China, 274099
    • Research Site
  • Jiujiang, China, 332000
    • Research Site
  • Luoyang, China, 471000
    • Research Site
  • Meihekou, China, 135022
    • Research Site
  • Nanchang, China, 330009
    • Research Site
  • Nanchong, China, 637900
    • Research Site
  • Nanjing, China, 210009
    • Research Site
  • Ningbo, China, 315020
    • Research Site
  • Panjin, China, 124009
    • Research Site
  • Puyang, China, 457000
    • Research Site
  • Qiqihar, China, 161000
    • Research Site
  • Sanya, China, 572000
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shanghai, China, 200040
    • Research Site
  • Shenyang, China, 110016
    • Research Site
  • Shenyang, China, 110004
    • Research Site
  • Taiyuan, China, 030024
    • Research Site
  • Tianjin, China
    • Research Site
  • Tianjin, China, 300457
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Wuhan, China, 430060
    • Research Site
  • Wuhan, China, 430010
    • Research Site
  • Xianyang, China, 712000
    • Research Site
  • Xianyang, China, 750004
    • Research Site
  • Xuzhou, China, 221000
    • Research Site
  • Yangzhou, China, 225001
    • Research Site
  • Yinchuan, China, 750001
    • Research Site
  • Zhengzhou, China
    • Research Site
  • Zigong, China, 643021
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
  • Hong Kong, Hong Kong, 00000
    • Research Site
  • Hong Kong, Hong Kong, 0000
    • Research Site
• India
  • Bangalore, India, 560 092
    • Research Site
  • Belgaum, India, 590016
    • Research Site
  • Kanpur, India, 208002
    • Research Site
  • New Delhi, India, 110060
    • Research Site
  • New Delhi, India, 110002
    • Research Site
  • Surat, India, 395001
    • Research Site
• Japan
  • Chuo-ku, Japan, 103-0027
    • Research Site
  • Chuo-ku, Japan, 260-0804
    • Research Site
  • Kagoshima-shi, Japan, 890-8520
    • Research Site
  • Minato-ku, Japan, 108-0073
    • Research Site
  • Tsukuba-shi, Japan, 305-0861
    • Research Site
  • Utsunomiya-shi, Japan, 320-8580
    • Research Site
  • Yokohama-shi, Japan, 236-0004
    • Research Site
  • Yokohama-shi, Japan, 234-0054
    • Research Site
• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Research Site
  • Seoul, Korea, Republic of, 02841
    • Research Site
  • Seoul, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 04763
    • Research Site
• Philippines
  • Iloilo City, Philippines, 5000
    • Research Site
  • Quezon City, Philippines, 1112
    • Research Site
• Russian Federation
  • St Petersburg, Russian Federation, 197341
    • Research Site
• Turkey
  • Ankara, Turkey, 06800
    • Research Site
  • Kahramanmaras, Turkey, 46100
    • Research Site
  • Kayseri, Turkey, 38039
    • Research Site
  • Kocaeli, Turkey, 41380
    • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Research Site
  • Ho Chi Minh, Vietnam, 700000
    • Research Site
  • Hochiminh, Vietnam, 70000
    • Research Site
  • Hochiminh city, Vietnam, 700000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female participants must be ≥ 18 years old
• Mean siSBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg and < 170 mmHg at Screening.

• Fulfil at least 1 of the following 2 criteria:

  1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
  2. rHTN subpopulation: have a stable regimen (≥ 4 weeks) of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
• Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
• Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening
• Mean siSBP on AOBPM ≥ 140 mmHg at Baseline.

Exclusion Criteria:

• Mean siSBP on AOBPM ≥ 170 mmHg at randomisation
• Mean siDBP on AOBPM ≥ 105 mmHg at randomization• Serum sodium level (Na+) < 135 mmol/L at Screening
• Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation
• NYHA functional heart failure class IV at Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 mg baxdrostat; 1 mg baxdrostat administered orally, once daily (QD).	Drug: Baxdrostat; Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: 1 mg per tablet for 1mg baxdrostat Arm; 2 mg per tablet for 2mg baxdrostat Arm; Other Names: CIN-107
Experimental: 2 mg baxdrostat; 2 mg baxdrostat administered orally, once daily (QD)	Drug: Baxdrostat; Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: 1 mg per tablet for 1mg baxdrostat Arm; 2 mg per tablet for 2mg baxdrostat Arm; Other Names: CIN-107
Placebo Comparator: placebo; Placebo administered orally, once daily (QD)	Drug: Placebo; Placebo tablet administered orally, once daily (QD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in siSBP at Week 12	To assess the effect of 2 mg baxdrostat versus placebo on siSBP at 12 weeks	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in siSBP at Week 12	To assess the effect of 1 mg baxdrostat versus placebo on siSBP at 12 weeks	At Week 12
Change from RWD baseline (Week 24) in siSBP at Week 32	To assess the effect of 2 mg baxdrostat versus placebo on siSBP at 8 weeks after randomised withdrawal	At Week 32
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM	To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12	At Week 12
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM	To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12	At Week 12
Change from baseline in siDBP at Week 12	To assess the effect of 2 mg baxdrostat versus placebo on siDBP at Week 12	At Week 12
Achieving siSBP < 140 mmHg at Week 12	To assess the effect of 2 mg baxdrostat versus placebo on achieving siSBP < 140 mmHg at Week 12	At Week 12
Change from baseline in siDBP at Week 12	To assess the effect of 1 mg baxdrostat versus placebo on siDBP at Week 12.	At Week 12
Achieving siSBP < 140 mmHg at Week 12	To assess the effect of 1 mg baxdrostat versus placebo on achieving siSBP < 140 mmHg at Week 12	At Week 12
Change from baseline in siSBP at Week 12	To assess the effect of 2 mg baxdrostat versus placebo on siSBP at Week 12 in the rHTN subgroup	At Week 12
Change from baseline in siSBP at Week 12	To assess the effect of 1 mg baxdrostat versus placebo on siSBP at Week 12 in the rHTN subgroup	At Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI)	Up to week 54

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): April 18, 2024
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Blood pressure; Uncontrolled hypertension; Aldosterone; Resistant hypertension; Baxdrostat; CIN-107; Aldosterone synthase
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: D6970C00008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No