Conditions: Essential Hypertension
Keywords: Essential hypertension Phase 2 study Antihypertensive agent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 628
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks. arm 2: Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks. arm 3: Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks. arm 4: Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks. arm 5: Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks. arm 6: Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks. arm 7: Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 8: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 9: Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 10: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 11: Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 12: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 13: Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 14: Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 15: Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 16: Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 17: Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).

Interventions: intervention 1: LCI699 intervention 2: Eplerenone intervention 3: LCI699-matching Placebo intervention 4: Eplerenone-matching Placebo
Intervention descriptions: intervention 1: LCI699 oral capsules intervention 2: Eplerenone oral capsules intervention 3: LCI699-matching placebo oral capsules intervention 4: Eplerenone-matching placebo oral capsules

Protocol document: