LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01373086
• Other study ID #: CLFF269X2201
• Status: Terminated
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• LFF269

• Eplerenone

• Placebo

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute-Phase I	Anaheim	California
United States	Comprehensive Phase I	Fort Myers	Florida
United States	Clinical Research Advantage/ Prairie Fields Family Medicine, PC	Fremont	Nebraska
United States	Clinical Research Advantage/ Aloha Medical	Las Vegas	Nevada
United States	Comprehensive Phase One®,	Miramar	Florida
United States	ICON Developmental Solutions	Omaha	Nebraska
United States	Internal Medicine Physicians	Omaha	Nebraska
United States	Comprehensive NeuroScience	Saint Petersburg	Florida
United States	ICON Development Solutions,	San Antonio	Texas
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Comprehensive Clinical Development NW, Inc.	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment		Baseline, week 4
Secondary	Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment		Baseline, week 4
Secondary	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
Secondary	Change from baseline in mean sitting SBP and DBP after 4 weeks treatment		Baseline, week 4
Secondary	Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough)		4 weeks
Secondary	change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment		Baseline, week 4
Secondary	Pharmacokinetics of LFF269: Plasma concentrations of LFF269		pre dose & 6 hours post study drug dose

External Links

•   Results for CLFF269X2201 from the Novartis Clinical Trials website