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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05968430




Registration number
NCT05968430
Ethics application status
Date submitted
14/07/2023
Date registered
1/08/2023

Titles & IDs
Public title
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension
Scientific title
An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension
Secondary ID [1] 0 0
MLS-101-901
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lorundrostat
Treatment: Drugs - Placebo

Experimental: Open-Label Arm - lorundrostat once daily for 36 or 48 weeks depending on when the subject enrolled

Experimental: RTW Substudy - lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy

Optional for subjects from the MLS-101-301 parent study only

Experimental: Optional Continuation Period - lorundrostat once daily from weeks 36 or 48 until marketing authorization or early termination of the trial by the sponsor


Treatment: Drugs: lorundrostat
Tablet, administered orally

Treatment: Drugs: Placebo
Tablet, administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from MLS-101-301 baseline automated office blood pressure
Timepoint [1] 0 0
Week 36
Primary outcome [2] 0 0
Change at MLS-101-901 Week 16 (RTW Week 4) from MLS 101-901 Week 12 (RTW substudy baseline) in AOBP SBP in subjects enrolled in RTW
Timepoint [2] 0 0
Week 16

Eligibility
Key inclusion criteria
1. Written informed consent signed by the participant, obtained before any study-related assessment is performed
2. At least 18 years of age at the time of signing the informed consent form (ICF)
3. Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol
4. Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug
5. Willing and able to comply with the study instructions and attend all scheduled study visits

[Randomized treatment withdrawal substudy only]
6. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant, plan to become pregnant, or are breast-feeding
2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
3. In the opinion of the Investigator, any condition that will preclude participation in the study

[Randomized treatment withdrawal substudy only]
4. Non-compliance with study medication(s) (defined as taking <75% or >125% of the study drug provided) during the first 12 weeks of MLS-101-901

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Renal Research - Gosford - Gosford
Recruitment hospital [2] 0 0
Castle Hill Medical Centre - Castle Hill
Recruitment hospital [3] 0 0
The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit. - Perth
Recruitment hospital [4] 0 0
University of Sunshine Coast Clinical Trial Centre - Sippy Downs
Recruitment hospital [5] 0 0
AusTrials - Taringa - Taringa
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
NSW 2154 - Castle Hill
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment postcode(s) [4] 0 0
QLD 4556 - Sippy Downs
Recruitment postcode(s) [5] 0 0
QLD 4068 - Taringa
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Mississippi
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Missouri
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Nebraska
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Nevada
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Bulgaria
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Gabrovo
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Bulgaria
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Veliko Tarnovo
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Canada
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Quebec
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Germany
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Berlin
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Germany
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Deggingen
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Germany
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Dresden
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Italy
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Messina
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Italy
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Roma
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Lodz
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Olsztyn
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Poland
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Skierniewice
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Warsaw
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Puerto Rico
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San Juan
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Romania
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Brasov
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Romania
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Bucure?ti
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Romania
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Timisoara
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Spain
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Badajoz
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Spain
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Córdoba
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Spain
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Granada
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Spain
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Valencia
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United Kingdom
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Cornwall
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England
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Scotland
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Wilts
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United Kingdom
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Cambridge
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London
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United Kingdom
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Plymouth
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United Kingdom
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Torpoint

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mineralys Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nicole Brown
Address 0 0
Country 0 0
Phone 0 0
888-378-6240
Fax 0 0
Email 0 0
nbrown@mineralystx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05968430