Phase 2
N=63
A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00817414 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of LCI699 With Respect to Effect on the Adrenocorticotropic Hormone (ACTH)-Stimulated Cortisol Response Following ACTH Stimulation in Hypertensive Participants — 1.30 milligrams (mg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LCI699-matching placebo (Drug); LCI699 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of LCI699 With Respect to Effect on the Adrenocorticotropic Hormone (ACTH)-Stimulated Cortisol Response Following ACTH Stimulation in Hypertensive Participants |
1.30 | — |
| SECONDARY LCI699 Exposure-response Relationship on Cortisol Levels Following ACTH Stimulation in Hypertensive Participants |
690.0; 669.40; 625.06; 562.04; 799.06; 634.87 | — |
| SECONDARY LCI699 Plasma Concentration Post LCI699 Administration at Day 7 |
1.51; 2.88; 3.92; 6.73 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of LCI699 |
1.42; 2.94; 4.62; 8.86 | — |
| SECONDARY Time of Maximum Plasma Concentration (Tmax) of LCI699 |
2.21; 1.00; 1.00; 1.00 | — |
| SECONDARY Area Under the Concentration Time Curve From Time 0 to 8 Hours Post LCI699 Administration (AUC0-8) |
6.60; 14.1; 24.1; 46.4 | — |
| SECONDARY Area Under the Concentration Time Curve Over the Dosing Interval (AUC0-τ) for LCI699 |
9.23; 18.8; 30.6; 68.9 | — |
| SECONDARY Apparent Terminal Half-life (T1/2) of LCI699 |
4.67; 3.79; 5.52; 4.90 | — |
| SECONDARY Number of Participants With Adverse Event (AEs) |
6; 9; 10; 10; 10 | — |
| SECONDARY Percentage of Participants With a Mean Sitting Systolic Blood Pressure (MSSBP) Response and MSSBP Control at Week 6 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) |
58.3; 50.0; 69.2; 76.9; 61.5; 50.0 | — |
| SECONDARY Percentage of Participants With a Mean Sitting Diastolic Blood Pressure (MSDBP) Response and MSDBP Control at Week 6 LOCF, as Measured by OBP |
58.3; 66.7; 100; 76.9; 61.5; 58.3 | — |
Summary
This study determined the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in participants with hypertension.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmHg) and 9%)
- Malignancies within the last 5 years (excluding basal cell skin cancer)
- Liver disease
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00817414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.