LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01373086

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: LFF269 Drug: Eplerenone Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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 [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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Research Institute-Phase I	Anaheim	California	United States	92801
2	Comprehensive Phase I	Fort Myers	Florida	United States	333901
3	Comprehensive Phase One®,	Miramar	Florida	United States	33025
4	Comprehensive NeuroScience	Saint Petersburg	Florida	United States	33716
5	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
6	Clinical Research Advantage/ Prairie Fields Family Medicine, PC	Fremont	Nebraska	United States	68025
7	Internal Medicine Physicians	Omaha	Nebraska	United States	68130
8	ICON Developmental Solutions	Omaha	Nebraska	United States	68154
9	Clinical Research Advantage/ Aloha Medical	Las Vegas	Nevada	United States	89183
10	ICON Development Solutions,	San Antonio	Texas	United States	78209
11	Comprehensive Clinical Development NW, Inc.	Tacoma	Washington	United States	98418