MLS-101-301: A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension

Conditions

Uncontrolled and Resistant Hypertension

Brief summary

Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

Detailed description

Proportion of subjects with AOBP SBP <130 mmHg at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo, Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat 50 mg QC with escalation to lorundrostat 100 mg QD compared to subjects randomized to placebo, Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to placebo, Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to placebo, Change from baseline in AOBP SBP at Week 6 by obesity status in in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo, Change from baseline in AOBP SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at Week 6 (within-subjects analysis)

Related papers

No related papers found yet.

Interventions

DRUGLorundrostat Placebo Tablets

DRUGLorundrostat

DRUGSynacthen 0

DRUG25 mg/ml Injektionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo	—

Secondary

Measure	Time frame
Proportion of subjects with AOBP SBP <130 mmHg at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo, Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat 50 mg QC with escalation to lorundrostat 100 mg QD compared to subjects randomized to placebo, Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to placebo, Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to placebo, Change from baseline in AOBP SBP at Week 6 by obesity status in in subjects randomize	—

Measure

Time frame

Proportion of subjects with AOBP SBP <130 mmHg at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo, Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat 50 mg QC with escalation to lorundrostat 100 mg QD compared to subjects randomized to placebo, Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to placebo, Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to placebo, Change from baseline in AOBP SBP at Week 6 by obesity status in in subjects randomize

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Countries

Bulgaria, France, Germany, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed