Trial intelligence / Profile preview

LCI699 Cortisol Effects in Hypertension

NCT00817414Phase 2

Key facts

Status: Completed
Start: Jan 2009
Primary completion: Aug 2009
Countries: 2
Sponsor: Novartis
Modality: Small Molecules

Drugs: osilodrostat
Conditions: hypertension (HTN)

Overview

Phase 2, randomised, double-blind trial of osilodrostat in hypertension (HTN) (5 arms), sponsored by Novartis. Primary endpoint: Maximum Tolerated Dose of LCI699 With Respect to Effect on the ACTH-Stimulated Cortisol Response. Started Jan 2009; status: completed.

Design

5 arms

Study design: RandomizedDouble-blind

Cohort A: LCI699 0.5 mg QD
LCI699 0.5 mg QD
Cohort A: LCI699 1.0 mg QD
LCI699 1.0 mg QD
Cohort B1: LCI699 1.0 mg BID
LCI699 1.0 mg BID
Cohort B1: LCI699 2.0 mg QD
LCI699 2.0 mg QD
Placebo
Matching placebo

Who it enrols

Adult patients with hypertension (BP 140/90 to 180/110 mmHg) on current treatment, weighing at least 50 kg. Excludes patients with recent cardiac events, significant ECG findings, Type 1 or uncontrolled Type 2 diabetes (HbA1c > 9%), liver disease, or recent malignancies.

Endpoints

Primary

Maximum Tolerated Dose of LCI699 With Respect to Effect on the ACTH-Stimulated Cortisol ResponseUp to Week 6

Secondary

LCI699 Exposure-response Relationship on Cortisol Levels Following ACTH StimulationUp to Week 6
Maximum Plasma Concentration of LCI699Day 42
Time of Maximum Plasma Concentration of LCI699Day 42
Area Under the Concentration Time Curve From Time 0 to 8 HoursDay 42
Number of Participants With Adverse EventsUp to 8 weeks
Percentage of Participants With a Mean Sitting Systolic Blood Pressure Response and ControlWeek 6
Percentage of Participants With a Mean Sitting Diastolic Blood Pressure Response and ControlWeek 6

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