Trial · NCT00619801

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin

NCT00619801, Phase 3, Completed, UCB Pharma; results first posted 2009-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin. Trials, record NCT00619801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00619801

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
NCT number: NCT00619801
Status: Completed
Phases: Phase 3
Enrollment: 173 participants, actual
Lead sponsor: UCB Pharma
Conditions: Allergic Rhinitis, Chronic Urticaria
Interventions: Levocetirizine, Placebo
First posted: 2008-02-21
Last updated: 2015-03-06
Other registries' IDs: eudract:2015-000205-39
Results first posted: 2009-09-04

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)	Baseline, 14 days
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval	Baseline, 14 days	The RR interval refers to the respective time interval in the Electrocardiogram (ECG).
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval	Baseline, 14 days	The PR interval refers to the respective time interval in the Electrocardiogram (ECG).
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration	Baseline, 14 days	The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval	Baseline, 14 days	The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)	Baseline, 14 days	The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Primary	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)	7 days	The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Primary	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)	14 days	The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Secondary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin	Baseline, 14 days
Secondary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)	Baseline, 14 days

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)	Baseline, 14 days	Safety Population; only non-missing values were analyzed	beats per minute	MEAN
PRIMARY	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval	Baseline, 14 days	Safety Population; only non-missing values were analyzed	milliseconds	MEAN
PRIMARY	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval	Baseline, 14 days	Safety Population; only non-missing values were analyzed	milliseconds	MEAN
PRIMARY	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration	Baseline, 14 days	Safety Population; only non-missing values were analyzed	milliseconds	MEAN
PRIMARY	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval	Baseline, 14 days	Safety Population; only non-missing values were analyzed	milliseconds	MEAN
PRIMARY	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)	Baseline, 14 days	Safety Population; only non-missing values were analyzed	milliseconds	MEAN
PRIMARY	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)	7 days	Safety Population; only non-missing values were analyzed	milliseconds	MEAN
PRIMARY	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)	14 days	Safety Population; only non-missing values were analyzed	milliseconds	MEAN
SECONDARY	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin	Baseline, 14 days	Safety Population; only non-missing values were analyzed	micromole per liter [µmol/L]	MEDIAN
SECONDARY	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)	Baseline, 14 days	Safety Population; only non-missing values were analyzed	unit per liter [U/L]	MEDIAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)	Placebo	-1.5	Standard Deviation 14.1	beats per minute
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)	Levocetirizine	1.3	Standard Deviation 14.2	beats per minute
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval	Placebo	9.2	Standard Deviation 85.9	milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval	Levocetirizine	-6.9	Standard Deviation 83.4	milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval	Placebo	0.5	Standard Deviation 9.6	milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval	Levocetirizine	-0.8	Standard Deviation 11.0	milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration	Placebo	0.3	Standard Deviation 6.6	milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration	Levocetirizine	0.9	Standard Deviation 7.1	milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval	Placebo	-2.8	Standard Deviation 17.2	milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval	Levocetirizine	-1.5	Standard Deviation 19.2	milliseconds

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	59
Overall Study	STARTED	Levocetirizine	114
Overall Study	Safety Population	Placebo	59
Overall Study	Safety Population	Levocetirizine	114
Overall Study	COMPLETED	Placebo	58
Overall Study	COMPLETED	Levocetirizine	111
Overall Study	NOT COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Levocetirizine	3

Source ClinicalTrials.gov

Adverse events112

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Tachycardia	Cardiac disorders	Placebo	0	59	0
other	Tachycardia	Cardiac disorders	Levocetirizine	1	114	1
other	Cerumen impaction	Ear and labyrinth disorders	Placebo	1	59	1
other	Cerumen impaction	Ear and labyrinth disorders	Levocetirizine	0	114	0
other	Eye swelling	Eye disorders	Placebo	0	59	0
other	Eye swelling	Eye disorders	Levocetirizine	1	114	1
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	59	2
other	Diarrhoea	Gastrointestinal disorders	Levocetirizine	4	114	4
other	Vomiting	Gastrointestinal disorders	Placebo	2	59	2
other	Vomiting	Gastrointestinal disorders	Levocetirizine	4	114	4

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Levocetirizine
Total, other adverse events	Placebo	21	59
Total, other adverse events	Levocetirizine	39	114
Total, serious adverse events	Placebo	0	59
Total, serious adverse events	Levocetirizine	1	114

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20819318	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Levocetirizine vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00619801

GET https://conductscience.org/api/trials/v1/NCT00619801/results?page=2

API reference For AI assistants