NCT00817635

A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.

Conditions

• 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: 2008-12-22
• Primary completion: 2009-10-13
• Completion: 2009-10-13
• First posted: 2009-01-06
• Last updated: 2021-06-02
• Results posted: 2021-06-02

Locations

38 sites across 2 countries: United States, Iceland

Regulatory

• FDA-regulated drug study