LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

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

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

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Eplerenone; Drug: LFF269

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CLFF269X2201 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension,; mild hypertension,; moderate hypertension,; high blood pressure,; uncomplicated hypertension.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Antihypertensive Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Eplerenone
• Other Study ID Numbers: CLFF269X2201