LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.

Official Title
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A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Proof-of-concept Study to Evaluate the Efficacy and Safety of LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: LFF269
* Drug: Eplerenone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LFF269 low dose<br>LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period | Drug: LFF269<br> <br> Drug: Placebo<br> <br> |
| Experimental: LFF269 high dose<br>LFF269 high dose + Matching Placebo to Eplerenone 50mg | Drug: LFF269<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Eplerenone<br>Eplerenone 50mg twice daily + matching placebo of LFF269 | Drug: Eplerenone<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 experiencing adverse events during the study as measure of safety and tolerability | Adverse events will be reported as percentage of patients with total adverse events, serious adverse events and death. | 4 weeks | 
| Change from baseline in mean sitting SBP and DBP 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 | 
| change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment |  | Baseline, week 4 | 
| Pharmacokinetics of LFF269: Plasma concentrations of LFF269 |  | pre dose & 6 hours post study drug dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension,, mild hypertension,, moderate hypertension,, high blood pressure,, uncomplicated hypertension.