Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007337-49 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Great Lakes Drug Development, Inc. | INDUSTRY |
| Integrium | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study determined the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in participants with hypertension.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCI699-matching placebo | Drug | LCI699-matching placebo oral capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| LCI699 Exposure-response Relationship on Cortisol Levels Following ACTH Stimulation in Hypertensive Participants | 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. | Up to Week 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Impact Clinical Trials | Beverly Hills | California | 90211 | United States | ||
| Associated Pharmaceutical Research Center, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24107737 | Derived | 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. |
Not provided
Not provided
A total of 63 participants with essential hypertension taking at least one anti-hypertensive treatment were randomized to receive LCI699 in comparison with placebo in an escalated dose design for 6 weeks.
Participants were enrolled at 10 investigative sites in the United States and Iceland from 14 January 2009 to 12 August 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: LCI699 0.5 mg QD | Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks. |
| FG001 | Cohort A: LCI699 1 mg QD | Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LCI699 |
| Drug |
LCI699 oral capsules |
|
| 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 |
| Area Under the Concentration Time Curve Over the Dosing Interval (AUC0-τ) for 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 |
| Apparent Terminal Half-life (T1/2) 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 |
| Number of Participants With Adverse Event (AEs) | 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. | Up to 8 weeks |
| 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) | 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 diabetic participants. | Week 6 |
| Percentage of Participants With a Mean Sitting Diastolic Blood Pressure (MSDBP) Response and MSDBP Control at Week 6 LOCF, as Measured by OBP | 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. | Week 6 |
| Buena Park |
| California |
| 90620 |
| United States |
| Innovative Clinical Research, Inc | Harbor City | California | 90710 | United States |
| Long Beach Center for Clinical Research | Long Beach | California | 90806 | United States |
| Metro Clinical Research | Littleton | Colorado | 80120 | United States |
| Clinical Study Center of Asheville, LLC | Asheville | North Carolina | 28801 | United States |
| Northstate Clinical Research | Lenoir | North Carolina | 28645 | United States |
| Tipton Medical & Diagnostic Center | Tipton | Pennsylvania | 16684 | United States |
| Punzi Medical Center | Carrollton | Texas | 75006 | United States |
| dgd Research, Inc | San Antonio | Texas | 78229 | United States |
| Encode Clinic | Reykjavik | SA | Iceland |
| FG002 | Cohort B1: LCI699 1 mg BID | Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks. |
| FG003 | Cohort B1: LCI699 2 mg QD | Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. |
| FG004 | Placebo | Participants received LCI699-matching placebo, capsules, orally, QD or BID with or without food for up to 6 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) population included all participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: LCI699 0.5 mg QD | Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks. |
| BG001 | Cohort A: LCI699 1 mg QD | Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. |
| BG002 | Cohort B1: LCI699 1 mg BID | Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks. |
| BG003 | Cohort B1: LCI699 2 mg QD | Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. |
| BG004 | Placebo | Participants received LCI699-matching placebo, capsules, orally, QD or BID with or without food for up to 6 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Safety set population included all participants who were randomized and received at least 1 dose of study drug. | Posted | Number | 90% Confidence Interval | milligrams (mg) | Up to Week 6 |
|
|
| |||||||||||||||||||||||||
| Secondary | LCI699 Exposure-response Relationship on Cortisol Levels Following ACTH Stimulation in Hypertensive Participants | 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. | Safety set population included all participants who were randomized and received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Error | nanomoles per liter (nmol/L) | Up to Week 6 |
| |||||||||||||||||||||||||||
| Secondary | LCI699 Plasma Concentration Post LCI699 Administration at Day 7 | Pharmacokinetic (PK) set population included all participants with sufficient LCI699 plasma samples at post-baseline visits. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose and 3 hours post-dose on Day 7 |
| ||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of LCI699 | PK set population included all participants with sufficient LCI699 plasma samples at post-baseline visits. Overall number analysed is the number of participants with data available for these analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
| ||||||||||||||||||||||||||||
| Secondary | Time of Maximum Plasma Concentration (Tmax) of LCI699 | PK set population included all participants with sufficient LCI699 plasma samples at post-baseline visits. Overall number analysed is the number of participants with data available for these analyses. | Posted | Median | Full Range | hour (hr) | 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 |
| ||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration Time Curve From Time 0 to 8 Hours Post LCI699 Administration (AUC0-8) | PK set population included all participants with sufficient LCI699 plasma samples at post-baseline visits. Overall number analysed is the number of participants with data available for these analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose |
| ||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration Time Curve Over the Dosing Interval (AUC0-τ) for LCI699 | PK set population included all participants with sufficient LCI699 plasma samples at post-baseline visits. Overall number analysed is the number of participants with data available for these analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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 |
| ||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Half-life (T1/2) of LCI699 | PK set population included all participants with sufficient LCI699 plasma samples at post-baseline visits. Overall number analysed is the number of participants with data available for these analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | 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 |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Event (AEs) | 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. | Safety set population included all participants who were randomized and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 8 weeks |
| ||||||||||||||||||||||||||||
| 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) | 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 diabetic participants. | FAS population included all participants who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 6 |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Mean Sitting Diastolic Blood Pressure (MSDBP) Response and MSDBP Control at Week 6 LOCF, as Measured by OBP | 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. | FAS population included all participants who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 6 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: LCI699 0.5 mg QD | Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks. | 0 | 12 | 0 | 12 | 6 | 12 |
| EG001 | Cohort A: LCI699 1.0 mg QD | Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. | 0 | 12 | 0 | 12 | 9 | 12 |
| EG002 | Cohort B1: LCI699 1.0 mg BID | Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks. | 0 | 13 | 0 | 13 | 10 | 13 |
| EG003 | Cohort B1: LCI699 2.0 mg QD | Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. | 0 | 13 | 0 | 13 | 10 | 13 |
| EG004 | Placebo | Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks. | 0 | 13 | 0 | 13 | 10 | 13 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| ACTH stimulation test abnormal | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C553306 | Osilodrostat |
Not provided
Not provided
Not provided
| Male |
|
| OG003 |
| Cohort B1: LCI699 2.0 mg QD |
Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. |
| OG004 | Placebo | Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| OG004 | Placebo | Participants received LCI699-matching placebo, capsules, orally, QD or BID with or without food for up to 6 weeks. |
|
|
Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks. |
| OG003 | Cohort B1: LCI699 2 mg QD | Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. |
| OG004 | Placebo | Participants received LCI699-matching placebo, capsules, orally, QD or BID with or without food for up to 6 weeks. |
|
|
Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks.
| OG003 | Cohort B1: LCI699 2 mg QD | Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. |
| OG004 | Placebo | Participants received LCI699-matching placebo, capsules, orally, QD or BID with or without food for up to 6 weeks. |
|
|
|
|