| Trial ID: | L0751 |
| Source ID: | NCT04162366
|
| Associated Drug: |
Aprocitentan 25 Mg
|
| Title: |
A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.
|
| Acronym: |
INSPIRE-CKD
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Renal Insufficiency, Chronic
|
| Interventions: |
DRUG: Aprocitentan 25 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement., From baseline to Week 4 after treatment initiation | Secondary: Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement., From baseline to Week 4 after treatment initiation|Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4, Evaluated in the subgroup of participants with a UACR greater than 30 mg/g at baseline., From baseline to Week 4 after treatment initiation
|
| Sponsor/Collaborators: |
Sponsor: Idorsia Pharmaceuticals Ltd. | Collaborators: Janssen Biotech, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-01
|
| Completion Date: |
2021-07-15
|
| Results First Posted: |
|
| Last Update Posted: |
2022-11-23
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT04162366
|
