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A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension

NCT00758524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 628

Last updated 2021-07-06

Study results available
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Summary

This study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.

Conditions

  • Essential Hypertension

Interventions

DRUG

LCI699

LCI699 oral capsules

DRUG

Eplerenone

Eplerenone oral capsules

DRUG

LCI699-matching Placebo

LCI699-matching placebo oral capsules

DRUG

Eplerenone-matching Placebo

Eplerenone-matching placebo oral capsules

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-11
Primary Completion
2009-07-02
Completion
2009-07-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00758524 on ClinicalTrials.gov