NCT01859923 is a Phase 2 clinical trial of Delamanid in Multidrug Resistant Tuberculosis, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who is sponsoring NCT01859923?

NCT01859923 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What drugs are being tested in NCT01859923?

Interventions in NCT01859923: Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR).

What condition does NCT01859923 study?

NCT01859923 studies Multidrug Resistant Tuberculosis.

Is NCT01859923 still recruiting?

NCT01859923 is currently completed. Last updated 23 November 2020.

Are results published for NCT01859923?

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

Last reviewed 2020-11-23 · How we verify

NCT01859923

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

A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)

Completed Phase 2 Results posted Last updated 23 November 2020

What this trial tests

Phase 2 trial testing Delamanid in Multidrug Resistant Tuberculosis in 37 participants. Completed in 13 January 2020.

Timeline

20 July 2013

Primary endpoint
13 January 2020

13 January 2020

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	20 July 2013
Primary completion	13 January 2020
Estimated completion	13 January 2020
Sites	3 locations across Philippines, South Africa

Drugs / interventions tested

Delamanid — full drug profile →
Delamanid Pediatric Formulation (DPF) — full drug profile →
Optimized Background Regimen (OBR) — full drug profile →

Conditions studied

Multidrug Resistant Tuberculosis — all drugs for Multidrug Resistant Tuberculosis →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Adults 0 to 17, any sex, with Multidrug Resistant Tuberculosis. 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.

Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) Primary · From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365)

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant and that does not necessarily have a causal relationship with the treatment. A TEAE is defined as an AE that occurred after the administration of investigational medicinal product (IMP).

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	7
Group 2: 6 to 11 Years of Age	6
Group 3: 3 to 5 Years of Age	12
Group 4: Birth to 2 Years of Age	12

Number of Participants With Abnormal Physical Examination Values Primary · From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365)

Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax; urogenital; audiometry assessment and visual assessment. Participants with abnormal values, as assessed by the investigator were reported.

Abdomen

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	1
Group 2: 6 to 11 Years of Age	1
Group 3: 3 to 5 Years of Age	4
Group 4: Birth to 2 Years of Age	2

Extremities

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	2
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	1
Group 4: Birth to 2 Years of Age	1

HEENT

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	7
Group 2: 6 to 11 Years of Age	6
Group 3: 3 to 5 Years of Age	12
Group 4: Birth to 2 Years of Age	10

Neurological

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	1
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	1
Group 4: Birth to 2 Years of Age	1

Skin and Mucosae

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	2
Group 2: 6 to 11 Years of Age	6
Group 3: 3 to 5 Years of Age	6
Group 4: Birth to 2 Years of Age	8

Thorax

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	5
Group 2: 6 to 11 Years of Age	2
Group 3: 3 to 5 Years of Age	6
Group 4: Birth to 2 Years of Age	7

Urogenital

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	0
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	1
Group 4: Birth to 2 Years of Age	3

Audiometry Assessment

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	4
Group 2: 6 to 11 Years of Age	3
Group 3: 3 to 5 Years of Age	9
Group 4: Birth to 2 Years of Age	7

Number of Participants With Clinically Significant Abnormal Vital Sign Values Primary · From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365)

Vital signs included weight (kg), height (cm), body temperature (degree Celsius), heart rate (beats/min), respiratory rate (breaths/minute), systolic and diastolic blood pressure (mm Hg), body mass index (BMI) (kg/m\^2). The criteria for clinically significant abnormal value for weight was decrease or increase of \>=5% in body weight relative to Baseline. Only categories with data for potentially clinically significant abnormal vital sign parameter values are reported.

Decrease of >=5% in Body Weight

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	0
Group 2: 6 to 11 Years of Age	2
Group 3: 3 to 5 Years of Age	0
Group 4: Birth to 2 Years of Age	1

Increase of >=5% in Body Weight

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	4
Group 2: 6 to 11 Years of Age	2
Group 3: 3 to 5 Years of Age	10
Group 4: Birth to 2 Years of Age	10

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values Primary · From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365)

The criteria for clinically significant abnormal ECG values were ventricular rate outlier (\<50 bpm and decrease of \>=25%, \>100 bpm and increase of \>=25%), PR outlier (increase of \>=25% when PR \>200 milliseconds (ms)), QRS outlier (increase of \>=25% when QRS \>100 ms), QT (new onset (in treatment period but not at Baseline) \[\>500 ms\]), QT interval corrected by Bazett's formula (QTcB) (new onset \[\>450, \>480, \>500 ms\], increase of \>=30 ms and \<= 60 ms or increase of \>60 ms), QT interval corrected by Fridericia's formula (QTcF) (new onset \[\>450, \>480, \>500 ms\], increase of \

Ventricular Rate Outliers, Notable Increases

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	1
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	1
Group 4: Birth to 2 Years of Age	4

QRS Outliers

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	1
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	0
Group 4: Birth to 2 Years of Age	0

QTcB, New Onset (>480 ms)

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	1
Group 2: 6 to 11 Years of Age	1
Group 3: 3 to 5 Years of Age	1
Group 4: Birth to 2 Years of Age	0

QTcB, New Onset (>450 ms)

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	7
Group 2: 6 to 11 Years of Age	2
Group 3: 3 to 5 Years of Age	8
Group 4: Birth to 2 Years of Age	5

QTcB, New Onset (Change >= 30 and <=60 ms)

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	5
Group 2: 6 to 11 Years of Age	3
Group 3: 3 to 5 Years of Age	8
Group 4: Birth to 2 Years of Age	9

QTcB, New Onset (Change > 60 ms)

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	1
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	0
Group 4: Birth to 2 Years of Age	2

QTcF, New Onset (>450 ms)

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	3
Group 2: 6 to 11 Years of Age	2
Group 3: 3 to 5 Years of Age	0
Group 4: Birth to 2 Years of Age	0

QTcF, New Onset (Change >= 30 and <=60 ms)

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	5
Group 2: 6 to 11 Years of Age	2
Group 3: 3 to 5 Years of Age	6
Group 4: Birth to 2 Years of Age	9

Number of Participants With Clinically Significant Laboratory Test Abnormalities Primary · From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365)

Laboratory assessments included parameters for serum chemistry, hematology and urinalysis along with adrenocorticotropic hormone, serum cortisol, free thyroxine, thyroid-stimulating hormone (TSH), and high sensitivity C-reactive protein cell count. The participants were categorized based on the clinically significant laboratory values as per protocol predefined criteria. The categories with at least one participant with clinically significant value outside the normal range for laboratory assessments are reported. The normal ranges for those laboratory parameters were potassium 3.4 - 5.4 millie

Elevated Potassium

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	0
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	0
Group 4: Birth to 2 Years of Age	1

Elevated Uric Acid

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	1
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	1
Group 4: Birth to 2 Years of Age	0

Elevated PTT

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	0
Group 2: 6 to 11 Years of Age	1
Group 3: 3 to 5 Years of Age	2
Group 4: Birth to 2 Years of Age	0

Low Platelet Count

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	0
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	0
Group 4: Birth to 2 Years of Age	1

Population Pharmacokinetic (POPPK) Model Point Estimate for Central Clearance (L) and Inter-compartmental Clearance (Q) of Delamanid Primary · Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238

Central clearance is defined as plasma volume in the vascular compartment that is cleared of drug per unit of time. Inter-compartmental clearance is defined as a ratio of the drug's distribution rate between the central compartment and the peripheral compartments over its circulating concentration (L/hr). Population point estimates were based on POPPK analysis to find one measure each for both L and Q. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid.

Central Clearance (L)

Group	Value	95% CI
Delamanid	18.1

Inter-compartmental Clearance (Q)

Group	Value	95% CI
Delamanid	105

POPPK Model Point Estimate for Central Volume of Distribution (Vc) and Peripheral Volume of Distribution (Vp) of Delamanid Primary · Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238

Vc is defined as the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma. Vp is defined as the apparent volume needed to account for the total amount of drug in the body if the drug was evenly distributed throughout the body and in the same concentration as the site of sample collection such as peripheral venous plasma. Population point estimates were based on POPPK analysis to find one measure each for both Vc and Vp. The exposure data were pooled across visits and participants to iden

Central Volume of Distribution (Vc)

Group	Value	95% CI
Delamanid	254

Peripheral Volume of Distribution (Vp)

Group	Value	95% CI
Delamanid	347

POPPK Model Point Estimate for Absorption Rate Constant (Ka) of Delamanid Primary · Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238

Ka is defined as a measure of rate at which a drug enters into the circulatory system. Population point estimate for Ka was based on population PK analysis to find one measure. Population point estimates were based on POPPK analysis to find one measure for Ka. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid.

Group	Value	95% CI
Delamanid	0.254

POPPK Model Point Estimate for Absorption Lag Time (ALAG1) of Delamanid Primary · Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238

ALAG1 is defined as the time delay prior to the commencement of drug absorption. Population point estimates were based on POPPK analysis to find one measure for ALAG1. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid.

Group	Value	95% CI
Delamanid	1.38

Baseline QT Interval (QTcB) Effect Secondary · Baseline (Day -1)

The 12-lead ECG was performed to obtain recordings of heart rate (QT interval) to analyze QTcB effect.

Delamanid

Group	Value	95% CI
Delamanid	0.0318	-0.113 – 0.177

Metabolite DM-6705

Group	Value	95% CI
Delamanid	0.0309	-0.112 – 0.174

PK/PD Relationship: POPPK Model Point Estimate for Slope of Linear Mixed Effects Model for Change in QTcB Interval Versus Delamanid Plasma Concentrations Secondary · Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238

The linear mixed effects model was applied to characterize the concentration-QTcB relationship of delamanid/DM-6705 to obtain population slope estimate.

Delamanid

Group	Value	95% CI
Delamanid	0.00792	-0.00132 – 0.0172

Metabolite DM-6705

Group	Value	95% CI
Delamanid	0.0613	0.016 – 0.107

Number of Participants With Treatment Outcome as Assessed by Principal Investigator Secondary · Month 24

Treatment outcome was defined as favorable (cured and completed treatment) and unfavorable (lost to follow-up or died).

Favorable (Cured + Treatment Completed)

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	6
Group 2: 6 to 11 Years of Age	6
Group 3: 3 to 5 Years of Age	10
Group 4: Birth to 2 Years of Age	11

Unfavorable (Lost To Follow-up + Died)

Group	Value	95% CI
Group 1: 12 to 17 Years of Age	1
Group 2: 6 to 11 Years of Age	0
Group 3: 3 to 5 Years of Age	2
Group 4: Birth to 2 Years of Age	1

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: 12 to 17 Years of Age

Serious: 0/7 (0%)

Deaths: 0/7

Group 2: 6 to 11 Years of Age

Serious: 1/6 (17%)

Deaths: 0/6

Group 3: 3 to 5 Years of Age

Serious: 2/12 (17%)

Deaths: 1/12

Group 4: Birth to 2 Years of Age

Serious: 5/12 (42%)

Deaths: 1/12

Serious adverse events (8 terms)

Reaction	System	Group 1: 12 to 17 Years of…	Group 2: 6 to 11 Years of …	Group 3: 3 to 5 Years of Age	Group 4: Birth to 2 Years …
Pneumonia	Infections and infestations	—	—	—	—
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	—	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—
Vulvovaginal candidiasis	Infections and infestations	—	—	—	—
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (122 terms — click to expand)

Reaction	System	Group 1: 12 to 17 Years of…	Group 2: 6 to 11 Years of …	Group 3: 3 to 5 Years of Age	Group 4: Birth to 2 Years …
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—
Acarodermatitis	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Weight decreased	Investigations	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Eosinophilia	Blood and lymphatic system disorders	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—	—
Parasitic gastroenteritis	Infections and infestations	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Craniocerebral injury	Injury, poisoning and procedural complications	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—
Blood corticotrophin increased	Investigations	—	—	—	—
Liver function test increased	Investigations	—	—	—	—
Prothrombin time prolonged	Investigations	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—
Deafness neurosensory	Ear and labyrinth disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	—	—	—	—
Wolff-Parkinson-White syndrome	Cardiac disorders	—	—	—	—
Cerumen impaction	Ear and labyrinth disorders	—	—	—	—
Conductive deafness	Ear and labyrinth disorders	—	—	—	—
Middle ear effusion	Ear and labyrinth disorders	—	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—	—
Vernal keratoconjunctivitis	Eye disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—

Most-reported serious reactions: Pneumonia, Immune thrombocytopenic purpura, Lower respiratory tract infection, Oral candidiasis, Vulvovaginal candidiasis, Non-Hodgkin's lymphoma, Lethargy, Bronchial hyperreactivity.

Data from ClinicalTrials.gov NCT01859923 adverse events section.

Sponsor's own description

The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in pediatric participants who completed Study 242-12-232 (NCT01856634).

Publications & conference data

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

Perspectives on Advances in Tuberculosis Diagnostics, Drugs, and Vaccines.
Schito M, Migliori GB, Fletcher HA, McNerney R, et al · · 2015 · cited 77× · PMID 26409271 · DOI 10.1093/cid/civ609
The role of delamanid in the treatment of drug-resistant tuberculosis.
Lewis JM, Sloan DJ. · · 2015 · cited 50× · PMID 25999726 · DOI 10.2147/tcrm.s71076
New anti-tuberculosis drugs and regimens: 2015 update.
D'Ambrosio L, Centis R, Sotgiu G, Pontali E, et al · · 2015 · cited 42× · PMID 27730131 · DOI 10.1183/23120541.00010-2015
New Drugs for the Treatment of Tuberculosis.
Ignatius EH, Dooley KE. · · 2019 · cited 39× · PMID 31731986 · DOI 10.1016/j.ccm.2019.08.001
Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons.
Gupta A, Hughes MD, Garcia-Prats AJ, McIntire K, et al · · 2019 · cited 34× · PMID 31415563 · DOI 10.1371/journal.pmed.1002882
Delamanid and bedaquiline to treat multidrug-resistant and extensively drug-resistant tuberculosis in children: a systematic review.
D'Ambrosio L, Centis R, Tiberi S, Tiberi S, et al · · 2017 · cited 26× · PMID 28840010 · DOI 10.21037/jtd.2017.06.16
Treatment of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis in Children: The Role of Bedaquiline and Delamanid.
Pecora F, Dal Canto G, Veronese P, Esposito S. · · 2021 · cited 20× · PMID 34067732 · DOI 10.3390/microorganisms9051074
Shortened tuberculosis treatment regimens: what is new?
Silva DR, Mello FCQ, Migliori GB. · · 2020 · cited 18× · PMID 32215450 · DOI 10.36416/1806-3756/e20200009

Verify or expand the search:

Other trials of Delamanid

Trials testing the same drug.

NCT06081361 — Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezol · Phase 3 · active not recruiting
NCT05766267 — Short-course Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2, PHASE3 · active not recruiting
NCT06224036 — Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis · Phase 2 · unknown
NCT05382312 — Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established A · Phase 2 · completed
NCT04421495 — Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China · Phase 4 · unknown

Other recruiting trials for Multidrug Resistant Tuberculosis

Currently open trials in the same condition.

NCT05081401 — Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tube · Phase 3 · recruiting

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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 NCT01859923 (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 Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 23 November 2020

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/NCT01859923.

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