NCT00817414 is a Phase 2 clinical trial of LCI699 in Hypertension, sponsored by Novartis.

Who is sponsoring NCT00817414?

NCT00817414 is sponsored by Novartis.

What drugs are being tested in NCT00817414?

Interventions in NCT00817414: LCI699-matching placebo, LCI699.

What condition does NCT00817414 study?

NCT00817414 studies Hypertension.

Is NCT00817414 still recruiting?

NCT00817414 is currently completed. Last updated 2 June 2021.

Are results published for NCT00817414?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-02 · How we verify

NCT00817414

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension

Completed Phase 2 Results posted Last updated 2 June 2021

What this trial tests

Phase 2 trial testing LCI699-matching placebo in Hypertension in 63 participants. Completed in 12 August 2009.

Timeline

14 January 2009

Primary endpoint
12 August 2009

12 August 2009

Quick facts

Lead sponsor	Novartis
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	63
Start date	14 January 2009
Primary completion	12 August 2009
Estimated completion	12 August 2009
Sites	11 locations across United States, Iceland

Drugs / interventions tested

LCI699-matching placebo
LCI699 — full drug profile →

Conditions studied

Hypertension — all drugs for Hypertension →

Sponsor

Novartis — full company profile →

Who can join

Adults 18 to 75, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Tolerated Dose (MTD) of LCI699 With Respect to Effect on the Adrenocorticotropic Hormone (ACTH)-Stimulated Cortisol Response Following ACTH Stimulation in Hypertensive Participants Primary · Up to Week 6

As per the protocol, MTD is the dose at which 4 participants exhibited ACTH-stimulated cortisol results \<400 nanomoles per liter (nmol/L). The change in the distribution across the treatments were analyzed using 1- way analysis of variance (ANOVA) for continuous variables.

Group	Value	95% CI
LCI699	1.30	0.88 – 1.81

LCI699 Exposure-response Relationship on Cortisol Levels Following ACTH Stimulation in Hypertensive Participants Secondary · Up to Week 6

Exposure-response relationship was assessed using ACTH stimulation test. Tests were done 2 hours after study drug administration (i.e., at peak LCI699 concentrations). An increase in cortisol greater than \>500 nmol at 60 minutes after ACTH administration was expected.

Day 7

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	690.0	± 32.288
Cohort A: LCI699 1.0 mg QD	669.40	± 30.903
Cohort B1: LCI699 1.0 mg BID	625.06	± 30.965
Cohort B1: LCI699 2.0 mg QD	562.04	± 30.325
Placebo	799.06	± 31.161

Day 28

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	634.87	± 32.181
Cohort A: LCI699 1.0 mg QD	573.41	± 30.642
Cohort B1: LCI699 1.0 mg BID	554.79	± 29.466
Cohort B1: LCI699 2.0 mg QD	539.09	± 32.826
Placebo	804.86	± 29.786

Day 42

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	647.51	± 45.593
Cohort A: LCI699 1.0 mg QD	626.08	± 45.441
Cohort B1: LCI699 1.0 mg BID	539.68	± 37.146
Cohort B1: LCI699 2.0 mg QD	479.91	± 48.865
Placebo	812.91	± 39.096

LCI699 Plasma Concentration Post LCI699 Administration at Day 7 Secondary · Predose and 3 hours post-dose on Day 7

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	1.51	± 36
Cohort A: LCI699 1.0 mg QD	2.88	± 41
Cohort B1: LCI699 1.0 mg BID	3.92	± 31
Cohort B1: LCI699 2.0 mg QD	6.73	± 23

Maximum Plasma Concentration (Cmax) of LCI699 Secondary · Days 7, 28: Pre-dose and 3 hours post-dose; Day 30: Pre-dose; Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	1.42	± 36
Cohort A: LCI699 1.0 mg QD	2.94	± 35
Cohort B1: LCI699 1.0 mg BID	4.62	± 35
Cohort B1: LCI699 2.0 mg QD	8.86	± 21

Time of Maximum Plasma Concentration (Tmax) of LCI699 Secondary · Days 7, 28: Pre-dose and 3 hours post-dose; Day 30: Pre-dose; Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	2.21	1.0 – 4.0
Cohort A: LCI699 1.0 mg QD	1.00	1.0 – 4.0
Cohort B1: LCI699 1.0 mg BID	1.00	0.5 – 4.0
Cohort B1: LCI699 2.0 mg QD	1.00	1.0 – 3.0

Area Under the Concentration Time Curve From Time 0 to 8 Hours Post LCI699 Administration (AUC0-8) Secondary · Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	6.60	± 42
Cohort A: LCI699 1.0 mg QD	14.1	± 30
Cohort B1: LCI699 1.0 mg BID	24.1	± 39
Cohort B1: LCI699 2.0 mg QD	46.4	± 13

Area Under the Concentration Time Curve Over the Dosing Interval (AUC0-τ) for LCI699 Secondary · Days 7, 28: Pre-dose and 3 hours post-dose; Day 30: Pre-dose; Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	9.23	± 50
Cohort A: LCI699 1.0 mg QD	18.8	± 51
Cohort B1: LCI699 1.0 mg BID	30.6	± 41
Cohort B1: LCI699 2.0 mg QD	68.9	± 19

Apparent Terminal Half-life (T1/2) of LCI699 Secondary · Days 7, 28: Pre-dose and 3 hours post-dose; Day 30: Pre-dose; Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	4.67	± 37
Cohort A: LCI699 1.0 mg QD	3.79	± 43
Cohort B1: LCI699 1.0 mg BID	5.52	± 33
Cohort B1: LCI699 2.0 mg QD	4.90	± 17

Number of Participants With Adverse Event (AEs) Secondary · Up to 8 weeks

An AE is an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives.

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	6
Cohort A: LCI699 1 mg QD	9
Cohort B1: LCI699 1 mg BID	10
Cohort B1: LCI699 2 mg QD	10
Placebo	10

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) Secondary · Week 6

Automated arterial BP determinations was made with an automated BP device (such as the Omron BP monitor) in accordance with the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV. Sitting and standing blood pressure (BP) and heart rate (HR) measurements were performed. MSSBP response was defined as the percentage of participants with a MSSBP \<140 mmHg or a \>=20 mmHg reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP \<140 mmHg for non-diabetic participants and \<130mHg for

MSSBP Response

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	58.3
Cohort A: LCI699 1 mg QD	50.0
Cohort B1: LCI699 1 mg BID	69.2
Cohort B1: LCI699 2 mg QD	76.9
Placebo	61.5

MSSBP Control

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	50.0
Cohort A: LCI699 1 mg QD	41.7
Cohort B1: LCI699 1 mg BID	61.5
Cohort B1: LCI699 2 mg QD	76.9
Placebo	53.8

Percentage of Participants With a Mean Sitting Diastolic Blood Pressure (MSDBP) Response and MSDBP Control at Week 6 LOCF, as Measured by OBP Secondary · Week 6

Automated arterial BP determinations was made with an automated BP device (such as the Omron BP monitor) in accordance with the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV. Sitting and standing BP and HR measurements were performed. MSDBP response was defined as the percentage of participants with a MSDBP \<90 mmHg or a \>= 10 mmHg reduction from baseline. MSDBP control was defined as the percentage of participants with a MSDBP \<90 mmHg for non-diabetic participants and \<80mHg for diabetic participants.

MSDBP Response

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	58.3
Cohort A: LCI699 1 mg QD	66.7
Cohort B1: LCI699 1 mg BID	100
Cohort B1: LCI699 2 mg QD	76.9
Placebo	61.5

MSDBP Control

Group	Value	95% CI
Cohort A: LCI699 0.5 mg QD	58.3
Cohort A: LCI699 1 mg QD	66.7
Cohort B1: LCI699 1 mg BID	76.9
Cohort B1: LCI699 2 mg QD	76.9
Placebo	46.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 8 weeks. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A: LCI699 0.5 mg QD

Serious: 0/12 (0%)

Deaths: 0/12

Cohort A: LCI699 1.0 mg QD

Serious: 0/12 (0%)

Deaths: 0/12

Cohort B1: LCI699 1.0 mg BID

Serious: 0/13 (0%)

Deaths: 0/13

Cohort B1: LCI699 2.0 mg QD

Serious: 0/13 (0%)

Deaths: 0/13

Placebo

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (57 terms — click to expand)

Reaction	System	Cohort A: LCI699 0.5 mg QD	Cohort A: LCI699 1.0 mg QD	Cohort B1: LCI699 1.0 mg BID	Cohort B1: LCI699 2.0 mg QD	Placebo
ACTH stimulation test abnormal	Investigations	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Eructation	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—
Diarrhoea infectious	Infections and infestations	—	—	—	—	—
Fungal skin infection	Infections and infestations	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—
Excoriation	Injury, poisoning and procedural complications	—	—	—	—	—
Muscle injury	Injury, poisoning and procedural complications	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—
Occult blood positive	Investigations	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT00817414 adverse events section.

Sponsor's own description

This study determined the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in participants with hypertension.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

The effects of aldosterone synthase inhibition on aldosterone and cortisol in patients with hypertension: a phase II, randomized, double-blind, placebo-controlled, multicenter study.
Andersen K, Hartman D, Peppard T, Hermann D, et al · · 2012 · cited 45× · PMID 22947355 · DOI 10.1111/j.1751-7176.2012.00667.x
Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy.
Schumacher CD, Steele RE, Brunner HR. · · 2013 · cited 38× · PMID 24107737 · DOI 10.1097/hjh.0b013e328363570c
Aldosterone Synthase Inhibitors for Resistant Hypertension: Pharmacological Insights - A Systematic Review.
Cicero AFG, Tocci G, Avagimyan A, Penson P, et al · · 2025 · cited 7× · PMID 40885884 · DOI 10.1007/s40265-025-02229-2
A perspective on small molecules targeting the renin-angiotensin-aldosterone system and their utility in cardiovascular diseases: exploring the structural insights for rational drug discovery and development.
Bansal N, Kathuria D, Babu AM, Dhiman S, et al · · 2025 · cited 2× · PMID 39925732 · DOI 10.1039/d4md00720d

Verify or expand the search:

Other trials of LCI699

Trials testing the same drug.

NCT03708900 — Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrom · Phase 2 · recruiting
NCT01331239 — Safety and Efficacy of LCI699 in Cushing's Disease Patients · Phase 2 · completed
NCT00817635 — A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension · Phase 2 · completed
NCT00758524 — A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension · Phase 2 · completed

Other recruiting trials for Hypertension

Currently open trials in the same condition.

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Other Novartis trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00817414 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis
Last refreshed: 2 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00817414.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00817414

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of LCI699

Other recruiting trials for Hypertension

Other Novartis trials

Verify against primary sources