| Trial ID: | L0814 |
| Source ID: | NCT05222191
|
| Associated Drug: |
Spironolactone
|
| Title: |
Spironolactone in CKD Enabled by Chlorthalidone: PILOT
|
| Acronym: |
SPICE PILOT
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency|Chronic Hypertension
|
| Interventions: |
DRUG: Spironolactone|DRUG: Chlorthalidone|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Systolic Automated Office Blood Pressure from baseline to 12 weeks between arms, Baseline to 12 Weeks | Secondary: Change in logarithmically transformed albumin/creatinine ratio from baseline to 12 weeks between arms, Baseline to 12 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Indiana Institute for Medical Research
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-02-01
|
| Completion Date: |
2023-12-12
|
| Results First Posted: |
|
| Last Update Posted: |
2023-08-14
|
| Locations: |
Richard L Roudebush VA Medical Center, Indianapolis, Indiana, 46202, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05222191
|
