Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline

Completed

Started Jan 2009

Shorter than P25 for phase_2 hypertension

Geographic Reach

2 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

First Submitted

Initial submission to the registry

January 5, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed

8 days until next milestone

Study Start

First participant enrolled

January 14, 2009

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2009

Completed

11.8 years until next milestone

Results Posted

Study results publicly available

June 2, 2021

Completed

Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

January 5, 2009

Results QC Date

May 6, 2021

Last Update Submit

May 6, 2021

Conditions

Hypertension

Keywords

Blood PressureHypertensionCortisol

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

LCI699 Exposure-response Relationship on Cortisol Levels Following ACTH Stimulation in Hypertensive Participants
Up to Week 6
LCI699 Plasma Concentration Post LCI699 Administration at Day 7
Predose and 3 hours post-dose on Day 7
Maximum Plasma Concentration (Cmax) of LCI699
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
Time of Maximum Plasma Concentration (Tmax) of LCI699
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
Area Under the Concentration Time Curve From Time 0 to 8 Hours Post LCI699 Administration (AUC0-8)
Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose
+5 more secondary outcomes

Study Arms (5)

Cohort A: LCI699 0.5 mg QD

EXPERIMENTAL

Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks.

Drug: LCI699

Cohort A: LCI699 1.0 mg QD

EXPERIMENTAL

Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.

Drug: LCI699

Cohort B1: LCI699 1.0 mg BID

EXPERIMENTAL

Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.

Drug: LCI699

Cohort B1: LCI699 2.0 mg QD

EXPERIMENTAL

Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks.

Drug: LCI699

Placebo

PLACEBO COMPARATOR

Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks.

Drug: LCI699-matching placebo

Interventions

LCI699-matching placeboDRUG

LCI699-matching placebo oral capsules

Placebo

LCI699DRUG

LCI699 oral capsules

Cohort A: LCI699 0.5 mg QDCohort A: LCI699 1.0 mg QDCohort B1: LCI699 1.0 mg BIDCohort B1: LCI699 2.0 mg QD

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmHg) and \< 180/110 mmHg on current antihypertensive treatment
Male and female participants 18-75 years of age
Participants must weigh at least 50 kilograms (kg)

You may not qualify if:

Recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebral accident or transient ischemic attack
Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c \[HbA1c\] \> 9%)
Malignancies within the last 5 years (excluding basal cell skin cancer)
Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novartislead
Great Lakes Drug Development, Inc.collaborator
Integriumcollaborator

Study Sites (11)

Impact Clinical Trials

Beverly Hills, California, 90211, United States

Location

Associated Pharmaceutical Research Center, Inc

Buena Park, California, 90620, United States

Location

Innovative Clinical Research, Inc

Harbor City, California, 90710, United States

Location

Long Beach Center for Clinical Research

Long Beach, California, 90806, United States

Location

Metro Clinical Research

Littleton, Colorado, 80120, United States

Location

Clinical Study Center of Asheville, LLC

Asheville, North Carolina, 28801, United States

Location

Northstate Clinical Research

Lenoir, North Carolina, 28645, United States

Location

Tipton Medical & Diagnostic Center

Tipton, Pennsylvania, 16684, United States

Location

Punzi Medical Center

Carrollton, Texas, 75006, United States

Location

dgd Research, Inc

San Antonio, Texas, 78229, United States

Location

Encode Clinic

Reykjavik, SA, Iceland

Location

Related Publications (1)

Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.
PMID: 24107737DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Osilodrostat

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title: Study Director
Organization: Novartis Pharmaceuticals

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

January 14, 2009

Primary Completion

August 12, 2009

Study Completion

August 12, 2009

Last Updated

June 2, 2021

Results First Posted

June 2, 2021

Record last verified: 2021-05

Locations

IC(1)US(10)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (5)

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

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations