Phase 2
N=155
A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00817635 ↗Enrolled (actual)
155
Serious AEs
0.7%
Results posted
Jun 2021
Primary outcome: Primary: Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) — -11.4; -13.1; -12.5; -18.7 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LCI699 (Drug); Eplerenone (Drug); LCI699-matching Placebo (Drug); Eplerenone-matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) |
-11.4; -13.1; -12.5; -18.7; -8.8 | — |
| SECONDARY Change From Baseline in MSDBP at Week 8 LOCF |
-4.5; -6.0; -6.1; -7.7; -4.8 | — |
| SECONDARY Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8, as Measured by Office Blood Pressure (OBP) |
54.8; 57.7; 41.9; 65.6; 42.4; 51.6 | — |
| SECONDARY Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8, as Measured by OBP |
67.7; 73.1; 71.0; 71.9; 57.6; 54.8 | — |
| SECONDARY Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSSBP at Week 8 |
-11.4; -13.1; -12.5 | — |
| SECONDARY Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSDBP at Week 8 |
-4.5; -6.0; -6.1 | — |
| SECONDARY Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) at Week 8 LOCF, as Measured by Ambulatory Blood Pressure Measurement (ABPM) |
-4.4; -5.7; -6.3; -15.7; -1.0; -4.9 | — |
| SECONDARY Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) at Week 8 LOCF, as Measured by ABPM |
1.0; -3.4; -3.7; -9.6; -0.2; 0.6 | — |
| SECONDARY Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime SBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM |
-7.8; -4.7; -8.1; -5.3; -6.8; -4.5 | — |
| SECONDARY Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime DBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM |
-4.3; -2.5; -3.9; -2.6; -4.5; -2.8 | — |
| SECONDARY Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), Hyperkalemia, and Hyponatremia |
15; 15; 8; 13; 16; 0 | — |
| SECONDARY Number of Participants With Cortisol Levels Below 500 Nmol/L at 1 Hour After Adrenocorticotropic Hormone (ACTH) Injection at Week 8 |
0; 1; 4; 0; 0 | — |
| SECONDARY Percent Change From Baseline in Renin-Angiotensin-Aldosterone-System (RAAS) Biomarker: Plasma Aldosterone (PA) in LCI699 Compared to Eplerenone 50 mg at Week 8 LOCF |
-22.3; -30.4; -53.1; 115.0 | — |
| SECONDARY Percent Change From Baseline in RAAS Biomarker: Plasma Renin Activity (PRA) in LCI699 Compared to Eplerenone 50mg at Week 8 LOCF |
41.6; 74.3; 107.7; 414.1 | — |
| SECONDARY Percent Change From Baseline in RAAS Biomarker: Active Renin (ARC) in LCI699 Compared to Eplerenone 50mg at Week 8 LOCF |
73.1; 72.8; 156.4; 430.6 | — |
| SECONDARY Percent Change From Baseline in RAAS Biomarker: Ratio of PA to PRA in LCI699 Compared to Eplerenone 50mg at Week 8 LOCF |
-46.7; -50.0; -78.3; -57.1 | — |
Summary
This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.
Eligibility Criteria
Inclusion criteria
- Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and 9%)
- Malignancies within the last 5 years (excluding basal cell skin cancer)
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00817635). 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.