Clinical Trials in Spain / NCT05968430
Active, not recruiting
Phase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
NCT05968430 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Hypertension
Investigational drug(s) / intervention(s)
lorundrostatPlacebo
lorundrostat: Tablet, administered orally
Placebo: Tablet, administered orally
Study summary
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Eligibility
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
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
Primary outcome measure(s)
- Change from MLS-101-301 baseline automated office blood pressure — Week 36
Change from MLS-101-301 baseline automated office blood pressure (AOBP) systolic blood pressure (SBP) at MLS-101-901 Week 36 in subjects who were enrolled in the lorundrostat arms of MLS-101-301 and were not assigned to the placebo arm of the MLS-101-901 RTW substudy - 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 — Week 16
Trial sites (177)
| Facility | City | Region | Status |
|---|---|---|---|
| Accel Research Sites (ARS) - Birmingham Clinical Research Unit | Birmingham | Alabama | |
| G & L Research LLC | Foley | Alabama | |
| Chandler Clinical Trials | Chandler | Arizona | |
| Arizona Kidney | Glendale | Arizona | |
| AKDHC Medical Research Services, AZ | Phoenix | Arizona | |
| Noble Clinical Research | Tucson | Arizona | |
| Del Sol Research Management, LLC | Tucson | Arizona | |
| Entertainment Medical Group, Inc | Beverly Hills | California | |
| CA Institute of Renal Research, CA | Chula Vista | California | |
| Amicis Research Center - Vacaville | Fairfield | California | |
| Amicis Research Center - Granada Hills | Granada Hills | California | |
| Marvel Clinical Research 002, LLC | Huntington Beach | California | |
| University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) | La Jolla | California | |
| Clinical Trials Research (CTR) - Lincoln | Lincoln | California | |
| Academic Medical Research Institute (AMRI) - Los Angeles | Los Angeles | California | |
| Cedars-Sinai Medical Center | Los Angeles | California | |
| Amicis Research Center - Mission Hills | Northridge | California | |
| Amicis Research Center-Northridge | Northridge | California | |
| Northridge Clinical Trials | Northridge | California | |
| Pasadena Clinical Trials | Pasadena | California | |
| Empire Clinical Research | Pomona | California | |
| Clinical Trials Research (CTR) - Sacramento | Sacramento | California | |
| Triwest Research Associates | San Diego | California | |
| San Jose Clinical Trials | San Jose | California | |
| Amicis Research Center - Valencia | Valencia | California | |
| Kidney & Hypertension Center - Victorville | Victorville | California | |
| Blue Coast Research Center (BCRC) | Vista | California | |
| Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research) | Vista | California | |
| Colorado Kidney (Denver) Nephrology | Denver | Colorado | |
| CMR of Greater New Haven | Hamden | Connecticut | |
| Qway Research | Hialeah | Florida | |
| Indago Research and Health Center | Hialeah | Florida | |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | |
| Nuovida Research Center Corp | Miami | Florida | |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | |
| Nephrology Associates of Central Florida | Orlando | Florida | |
| AES - Orlando | Orlando | Florida | |
| Pines Care Research Center | Pembroke Pines | Florida | |
| Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) | Pembroke Pines | Florida | |
| Progressive Medical Research | Port Orange | Florida |
+ 137 more sites — see the full list on the official registry below.
Other trials for the same condition
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05968430 on ClinicalTrials.gov ↗ ← All trials in Spain