LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

Novartis

Status and phase: Terminated; Phase 2

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Eplerenone; Drug: LFF269

Study type: Interventional

Funder types: Industry

Identifiers

NCT01373086

CLFF269X2201

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 4 patient groups, including a placebo group

LFF269 low dose

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: LFF269

LFF269 high dose

Experimental group

Description:

LFF269 high dose + Matching Placebo to Eplerenone 50mg

Treatment:

Drug: Placebo

Drug: LFF269

Eplerenone

Active Comparator group

Description:

Eplerenone 50mg twice daily + matching placebo of LFF269

Treatment:

Drug: Placebo

Drug: Eplerenone

Placebo

Placebo Comparator group

Description:

Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg

Treatment:

Drug: Placebo