Hypertension Clinical Trial
Official title:
A 12 Week, Phase II Trial of the Safety, Pharmacokinetics, and Efficacy of INV-144 Compared With Losartan Potassium in Patients With Hypertension and Type 2 Diabetes Mellitus With Nephropathy
A randomized, double-blind, active control trial to determine the safety, efficacy and pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.
A multicenter, randomized, double-blind, parallel-group, active-control trial is designed to
evaluate the safety and efficacy of INV-144 versus losartan plus placebo co-administered
once daily for 12 weeks in subjects who have type 2 diabetes and hypertension with
nephropathy as evidenced by albuminuria.
Approximately 92 adult subjects will be enrolled and randomized in a 1:1 ratio to receive
either INV-144 or losartan plus placebo once daily for 12 weeks. The goal is to have
approximately 80 subjects complete the entire study.
The trial will consist of a 4-week open-label losartan run-in period, a 12-week double-blind
active treatment period, and a 4-week safety follow-up period. Efficacy will be evaluated by
measurement of UACR, systolic and diastolic blood pressure, and the HOMA-IR ratio. Safety
will be monitored throughout the study by evaluation of adverse events (AEs), physical
examinations (PEs), clinical laboratory results, vital signs, and electrocardiograms (ECGs).
Blood samples for PK analysis will be obtained in a subset of approximately 22 subjects, at
2 to 4 sites, to ensure that PK data are obtained from a minimum of 9 subjects in each
treatment arm.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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