LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension - Full Text View

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: LFF269 Drug: Eplerenone Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Eplerenone

U.S. FDA Resources

Further study details as provided by Novartis:

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 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
Percentage of patients experiencing adverse events during the study as measure of safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Pharmacokinetics of LFF269: Plasma concentrations of LFF269 [ Time Frame: pre dose & 6 hours post study drug dose ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	May 2011
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Criteria

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:

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373086

Locations

United States, California
Advanced Clinical Research Institute-Phase I
Anaheim, California, United States, 92801
United States, Florida
Comprehensive Phase I
Fort Myers, Florida, United States, 333901
Comprehensive Phase One®,
Miramar, Florida, United States, 33025
Comprehensive NeuroScience
St Petersburg, Florida, United States, 33716
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Nebraska
Clinical Research Advantage/ Prairie Fields Family Medicine, PC
Fremont, Nebraska, United States, 68025
ICON Developmental Solutions
Omaha, Nebraska, United States, 68154
Internal Medicine Physicians
Omaha, Nebraska, United States, 68130
United States, Nevada
Clinical Research Advantage/ Aloha Medical
Las Vegas, Nevada, United States, 89183
United States, Texas
ICON Development Solutions,
San Antonio, Texas, United States, 78209
United States, Washington
Comprehensive Clinical Development NW, Inc.
Tacoma, Washington, United States, 98418

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01373086 History of Changes
Other Study ID Numbers:	CLFF269X2201
Study First Received:	May 24, 2011
Last Updated:	November 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension,
mild hypertension,
moderate hypertension,
high blood pressure,
uncomplicated hypertension.

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Eplerenone
Aldosterone Antagonists

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013