Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gedeon Richter Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cariprazine 3mg | Experimental | Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
|
| Cariprazine 6mg | Experimental | Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
|
| Aripiprazole 10mg | Active Comparator | Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
|
| Placebo | Placebo Comparator | Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine | Drug | Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. | The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S) | The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raffaele Migliore, MA | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group, Inc. | Little Rock | Arkansas | 72211 | United States | ||
| Woodland Research Northwest, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26845266 | Background | Citrome L, Durgam S, Lu K, Ferguson P, Laszlovszky I. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials. J Clin Psychiatry. 2016 Jan;77(1):109-15. doi: 10.4088/JCP.15m10192. | |
| 28692485 | Background | Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187. |
Not provided
Not provided
Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study. No-drug washout period of up to 7 days.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Oral administration. Once per day. |
| FG001 | Cariprazine 3.0 mg | Oral administration. Once per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Aripiprazole | Drug | Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
|
| Placebo | Drug | Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
|
| Baseline to Week 6 |
| Springdale |
| Arkansas |
| 72764 |
| United States |
| Synergy Clinical Research of Escondido | Escondido | California | 92025 | United States |
| Excell Research, Inc | Oceanside | California | 92056 | United States |
| Clinical Innovations, Inc. | Riverside | California | 92506 | United States |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | United States |
| Collaborative Neuroscience Network, Inc. | Torrance | California | 90502 | United States |
| Colorado Clinical Trials, Inc. | Littleton | Colorado | 80130 | United States |
| Comprehensive Clinical Development, Inc. | Washington D.C. | District of Columbia | 20016 | United States |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34208 | United States |
| Hawaii Clinical Research Center | Honolulu | Hawaii | 96813 | United States |
| Uptown Research Institute, LLC | Chicago | Illinois | 60640 | United States |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri | 63141 | United States |
| CRI Worldwide, LLC | Willingboro | New Jersey | 08046 | United States |
| Windsor-Laurelwood Center for Behavioral Medicine | Willoughby | Ohio | 44094 | United States |
| Vanderbilt Psychiatric Hospital | Nashville | Tennessee | 37212 | United States |
| Claghorn-Lesem Research Clinic, Ltd. | Houston | Texas | 77008 | United States |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | United States |
| Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie | Bucharest | 041914 | Romania |
| Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie | Bucharest | 41914 | Romania |
| Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie | Bucharest | 41914 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III | Cluj-Napoca | 400012 | Romania |
| Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie | Craiova | 200620 | Romania |
| Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie | Craiova | 200745 | Romania |
| Spitalul Judetean de Urgenta Piatra Neamt | Piatra Neamţ | 610136 | Romania |
| Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie | Piteşti | 110069 | Romania |
| Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu | Sibiu | 550082 | Romania |
| Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie | Targoviste | 130086 | Romania |
| Spitalul Clinic Judetean Mures, Clinica Psihiatrie I | Târgu Mureş | 540142 | Romania |
| Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil" | Timișoara | 300736 | Romania |
| Healthcare Institution "Moscow Regional Mental Hospital #5" | Orekhovo-Zuyevo | Moscow Oblast | 142601 | Russia |
| State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital> | Arkhangelsk | 163530 | Russia |
| State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1" | Chelyabinsk | 454087 | Russia |
| State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav" | Chita | 672090 | Russia |
| St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko" | Gatchina | 188357 | Russia |
| St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital" | Saint Petersburg | 190121 | Russia |
| Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Ministry of Health and Social Development of the Russian Federation, Department of biological therapy of mental patients | Saint Petersburg | 192019 | Russia |
| State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev" | Saint Petersburg | 192019 | Russia |
| Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Minitstry of Health and Social Development of the Russian Federation | Saint Petersburg | 1922019 | Russia |
| St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)" | Saint Petersburg | 193167 | Russia |
| St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7 | Saint Petersburg | 197341 | Russia |
| Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky" | Saratov | 410028 | Russia |
| State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital" | Saratov | 410060 | Russia |
| Regional State Healthcare Institution "Tomsk Clinical Mental Hospital" | Tomsk | 634014 | Russia |
| Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14 | Village Glevakha | Kyiv Oblast | 08613 | Ukraine |
| I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology | Dnipropetrovsk | 49005 | Ukraine |
| Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology | Dnipropetrovsk | 49027 | Ukraine |
| Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology | Donetsk | 83008 | Ukraine |
| Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14 | Kharkiv | 61068 | Ukraine |
| State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology | Kharkiv | 61068 | Ukraine |
| Kherson Regional Psychiatric Hospital, Department #3 | Kherson | 73488 | Ukraine |
| Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions | Kyiv | 04080 | Ukraine |
| Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female) | Lviv | 79021 | Ukraine |
| O.F. Maltsev Poltava Regional Clinical Psychiatric Hopspital, Department #3B, State Institution of Higher Education of Ukraine: Ukranian Medical Stomatological Academy, Chair of Psychiatry, Narcology and Medical Psychology | Poltava | 36006 | Ukraine |
| Crimean Republican Institution: Clinical Psychiatric Hospital #1, Female Psychiatric Department #2, Male Psychiatric Department #1, S.I. Georgiyevskyy Crimean State Medical University, Chair of Psychiatry, Psychotherapy and Narcology | Simferopol | 95006 | Ukraine |
| O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology | Vinnytsia | 49005 | Ukraine |
| 28836957 | Background | Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z. |
| 26717533 | Result | Durgam S, Cutler AJ, Lu K, Migliore R, Ruth A, Laszlovszky I, Nemeth G, Meltzer HY. Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo- and active-controlled trial. J Clin Psychiatry. 2015 Dec;76(12):e1574-82. doi: 10.4088/JCP.15m09997. |
| 34091867 | Derived | Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6. |
| 33854317 | Derived | Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021. |
| 30470662 | Derived | Marder S, Fleischhacker WW, Earley W, Lu K, Zhong Y, Nemeth G, Laszlovszky I, Szalai E, Durgam S. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies. Eur Neuropsychopharmacol. 2019 Jan;29(1):127-136. doi: 10.1016/j.euroneuro.2018.10.008. Epub 2018 Nov 20. |
| 28478771 | Derived | Cutler AJ, Durgam S, Wang Y, Migliore R, Lu K, Laszlovszky I, Nemeth G. Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8. |
| FG002 |
| Cariprazine 6.0mg |
Oral administration. Once per day. |
| FG003 | Aripiprazole 10.0 mg | Oral administration. Once per day. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The randomized population is also the safety population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Oral administration. Once per day. |
| BG001 | Cariprazine 3.0 mg | Oral administration. Once per day. |
| BG002 | Cariprazine 6.0mg | Oral administration. Once per day. |
| BG003 | Aripiprazole 10.0 mg | Oral administration. Once per day. |
| BG004 | 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/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. | The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement. | Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline to Week 6 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S) | The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement. | Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline to Week 6 |
|
Assessed over 2 months
Data is for the Double-blinding treatment period
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 | Placebo | Oral administration. Once per day. | 0 | 153 | 2 | 153 | 68 | 153 |
| EG001 | Cariprazine 3.0 mg | Oral administration. Once per day. | 0 | 155 | 4 | 155 | 61 | 155 |
| EG002 | Cariprazine 6.0mg | Oral administration. Once per day. | 2 | 157 | 7 | 157 | 71 | 157 |
| EG003 | Aripiprazole 10.0 mg | Oral administration. Once per day. | 0 | 152 | 4 | 152 | 61 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Complete Suicide | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dehydration | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ischemic stroke | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Social stay hospitalization | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Artropod bite | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vaginal Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Allergan | 877-277-8566 | IR-CTRegistration@Allergan.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C533287 | cariprazine |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Female |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African-American |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Missing |
|
| Mean Difference (Final Values) |
| -8.8 |
| 2-Sided |
| 95 |
| -12.9 |
| -4.7 |
| Superiority |
| ANCOVA | 0.0008 | Median Difference (Final Values) | -7.0 | 2-Sided | 95 | -11.0 | -2.9 | Superiority |
Oral administration. Once per day. |
|
|
|