| Trial ID: | L7145 |
| Source ID: | NCT01804777
|
| Associated Drug: |
Amiloride
|
| Title: |
Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Proteinuria|Hypertension|Type II Diabetes
|
| Interventions: |
DRUG: Amiloride|DRUG: HCTZ
|
| Outcome Measures: |
Primary: Blood Pressure, Change in clinic systolic BP. This BP measure will be the average of three serial BP measurements taken one minute apart after 5 minutes of sitting quietly., one month | Secondary: Hypertension, To demonstrate effect size on relevant hypertension outcomes such as volume status and urinary sodium excretion. Also assess the fractional excretion of sodium (FENa) and chloride (FECI). Endpoint will be the 24 hour urine excretion., one month
|
| Sponsor/Collaborators: |
Sponsor: University of New Mexico | Collaborators: Dialysis Clinic, Inc.|University of Pittsburgh
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
9
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
|
| Start Date: |
2013-03
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2018-05-11
|
| Locations: |
University of New Mexico Hospital; Clinical & Translational Science Center, Albuquerque, New Mexico, 87131, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01804777
|
