NCT00758524

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

A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Finding Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 628 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-09-11
• Primary completion: 2009-07-02
• Completion: 2009-07-02
• First posted: 2008-09-25
• Last updated: 2021-07-06
• Results posted: 2021-07-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study