The purpose of the present study was to determine whether LHW090 displays the clinical safety and efficacy profile to support further development in patients with resistant hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
North Hollywood, California, United States
Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
Number of participants with AEs, SAEs and deaths were assessed.
Time frame: 6 months
Change From Baseline in Mean Daytime Blood Pressure
Change in the 12 hour average of systolic blood pressure (SBP) measured by ambulatory blood pressure was defined as the 12 hour daytime average SBP on Day 28 minus the 12 hour daytime average SBP on Day -1. monitoring (ABPM). A negative change from baseline indicates improvement.
Time frame: Baseline, day 27
Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)
Blood samples were collected to assess Cmax.
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)
Blood samples were collected to assess Tmax.
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Blood samples were collected to assess AUClast.
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)
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Novartis Investigative Site
Atlantis, Florida, United States
Novartis Investigative Site
Daytona Beach, Florida, United States
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Honolulu, Hawaii, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
Gentofte Municipality, Denmark
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Berlin, Germany
...and 6 more locations
Blood samples were collected to assess Clast.
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast
Blood samples were collected to assess Tlast.
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28