drugset / Trial / NCT00758524
A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2008-09-11
- Primary completion
- 2009-07-02
- Completion
- 2009-07-02
Publications
- Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.
- Calhoun DA, White WB, Krum H, Guo W, Bermann G, Trapani A, Lefkowitz MP, Menard J. Effects of a novel aldosterone synthase inhibitor for treatment of primary hypertension: results of a randomized, double-blind, placebo- and active-controlled phase 2 trial. Circulation. 2011 Nov 1;124(18):1945-55. doi: 10.1161/CIRCULATIONAHA.111.029892. Epub 2011 Oct 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Eplerenone | Unknown | 50 mg | Oral |
| Subject | osilodrostat | Small molecule | 0.25 mg | Oral |
| Subject | osilodrostat | Small molecule | 0.5 mg | Oral |
| Subject | osilodrostat | Small molecule | 1 mg | Oral |