LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

Phase 2TerminatedNCT01373086

Novartis Pharmaceuticals19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

LFF269DRUG

EplerenoneDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. 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

Locations (11)

Advanced Clinical Research Institute-Phase I

Anaheim, California, United States

Comprehensive Phase I

Fort Myers, Florida, United States

Comprehensive Phase One®,

Miramar, Florida, United States

Outcomes

Primary Outcomes

Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment

Time frame: Baseline, week 4

Secondary Outcomes

Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment

Time frame: Baseline, week 4

Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment

Time frame: 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.

Time frame: 4 weeks

Change from baseline in mean sitting SBP and DBP after 4 weeks treatment

Time frame: Baseline, week 4

Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough)

Time frame: 4 weeks

change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment

Time frame: Baseline, week 4

Pharmacokinetics of LFF269: Plasma concentrations of LFF269

Time frame: pre dose & 6 hours post study drug dose

Data from ClinicalTrials.gov

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