LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension
- Registration Number
- NCT01373086
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- Male and female (post-menopausal or surgically sterile).
- Age from 18 to 75 years inclusive.
- Subjects with mild-to-moderate uncomplicated essential hypertension, with (not more than 2 in combination) or without prior treatment.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.
- History or evidence of a secondary form of hypertension,
- History of cardiovascular disease. Type 1 or type 2 diabetes mellitus.
- Clinically significant valvular heart disease.
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LFF269 low dose LFF269 LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period LFF269 low dose Placebo LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period LFF269 high dose LFF269 LFF269 high dose + Matching Placebo to Eplerenone 50mg LFF269 high dose Placebo LFF269 high dose + Matching Placebo to Eplerenone 50mg Eplerenone Eplerenone Eplerenone 50mg twice daily + matching placebo of LFF269 Eplerenone Placebo Eplerenone 50mg twice daily + matching placebo of LFF269 Placebo Placebo Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg
- Primary Outcome Measures
Name Time Method Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment Baseline, week 4
- Secondary Outcome Measures
Name Time Method Change from baseline in mean sitting SBP and DBP after 4 weeks treatment Baseline, week 4 change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment Baseline, week 4 Percentage of patients experiencing adverse events during the study as measure of safety and tolerability 4 weeks Adverse events will be reported as percentage of patients with total adverse events, serious adverse events and death.
Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment Baseline, week 4 Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment Baseline, week 4 Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough) 4 weeks Pharmacokinetics of LFF269: Plasma concentrations of LFF269 pre dose & 6 hours post study drug dose
Trial Locations
- Locations (11)
Comprehensive Phase I
🇺🇸Fort Myers, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Internal Medicine Physicians
🇺🇸Omaha, Nebraska, United States
Comprehensive Clinical Development NW, Inc.
🇺🇸Tacoma, Washington, United States
Comprehensive NeuroScience
🇺🇸Saint Petersburg, Florida, United States
Advanced Clinical Research Institute-Phase I
🇺🇸Anaheim, California, United States
Clinical Research Advantage/ Aloha Medical
🇺🇸Las Vegas, Nevada, United States
Comprehensive Phase One®,
🇺🇸Miramar, Florida, United States
Clinical Research Advantage/ Prairie Fields Family Medicine, PC
🇺🇸Fremont, Nebraska, United States
ICON Development Solutions,
🇺🇸San Antonio, Texas, United States
ICON Developmental Solutions
🇺🇸Omaha, Nebraska, United States