LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

Phase 2

Terminated

• Conditions: Hypertension
• Interventions: Drug: LFF269; Drug: Eplerenone; Drug: Placebo

• 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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-30
• Disposition First Submitted QC: 2012-11-30
• Disposition First Posted: 2012-12-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Male and female (post-menopausal or surgically sterile).
2. Age from 18 to 75 years inclusive.
3. Subjects with mild-to-moderate uncomplicated essential hypertension, with (not more than 2 in combination) or without prior treatment.
4. 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.

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Exclusion Criteria

1. History or evidence of a secondary form of hypertension,
2. History of cardiovascular disease. Type 1 or type 2 diabetes mellitus.
3. Clinically significant valvular heart disease.

Other protocol-defined inclusion/exclusion criteria may apply

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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