NCT01373086

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 17, 2020

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

May 24, 2011

Last Update Submit

December 11, 2020

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (4)

LFF269 low dose

EXPERIMENTAL

LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period

Drug: LFF269Drug: Placebo

LFF269 high dose

EXPERIMENTAL

LFF269 high dose + Matching Placebo to Eplerenone 50mg

Drug: LFF269Drug: Placebo

Eplerenone

ACTIVE COMPARATOR

Eplerenone 50mg twice daily + matching placebo of LFF269

Drug: EplerenoneDrug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg

Drug: Placebo

Interventions

LFF269DRUG
LFF269 high doseLFF269 low dose
EplerenoneDRUG
Eplerenone
PlaceboDRUG
EplerenoneLFF269 high doseLFF269 low dosePlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Advanced Clinical Research Institute-Phase I

Anaheim, California, 92801, United States

Location

Comprehensive Phase I

Fort Myers, Florida, 333901, United States

Location

Comprehensive Phase One®,

Miramar, Florida, 33025, United States

Location

Comprehensive NeuroScience

St. Petersburg, Florida, 33716, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Clinical Research Advantage/ Prairie Fields Family Medicine, PC

Fremont, Nebraska, 68025, United States

Location

Internal Medicine Physicians

Omaha, Nebraska, 68130, United States

Location

ICON Developmental Solutions

Omaha, Nebraska, 68154, United States

Location

Clinical Research Advantage/ Aloha Medical

Las Vegas, Nevada, 89183, United States

Location

ICON Development Solutions,

San Antonio, Texas, 78209, United States

Location

Comprehensive Clinical Development NW, Inc.

Tacoma, Washington, 98418, United States

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2011

First Posted

June 14, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 17, 2020

Record last verified: 2012-11

Locations

US(11)