NCT00756938

Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)

Completed Phase 3 Results posted Last updated 18 June 2024

What this trial tests

Phase 3 trial testing losartan potassium in Hypertension in 101 participants. Completed in 14 August 2012.

Timeline

1 March 2009

Primary endpoint
14 August 2012

14 August 2012

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	101
Start date	1 March 2009
Primary completion	14 August 2012
Estimated completion	14 August 2012

Drugs / interventions tested

• losartan potassium (LOSARTAN POTASSIUM) — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 6 Months to 6, any sex, with Hypertension. 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.

Mean Change From Baseline in Systolic Blood Pressure Primary · Baseline and Day 21

Sitting blood pressure (\[BP\] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.

Group	Value	95% CI
Losartan Potassium 0.1 to 1.4 mg/kg	-7.31	± 12.53
Losartan Potassium 0.3 to 1.4 mg/kg	-7.65	± 7.49
Losartan Potassium 0.7 to 1.4 mg/kg	-6.67	± 7.86

Mean Change From Baseline in Diastolic Blood Pressure Secondary · Baseline and Day 21

Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.

Group	Value	95% CI
Losartan Potassium 0.1 to 1.4 mg/kg	-8.25	± 11.76
Losartan Potassium 0.3 to 1.4 mg/kg	-5.15	± 8.06
Losartan Potassium 0.7 to 1.4 mg/kg	-6.73	± 8.59

Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s) Primary · up to 12 weeks (Base Study); up to 24 months (Extension)

Clinical Adverse Event

Group	Value	95% CI
Base Study-Losartan Potassium 0.1 mg/kg	21
Base Study-Losartan Potassium 0.3 mg/kg	30
Base Study-Losartan Potassium 0.7 mg/kg	36
Base Study-Losartan Potassium 1.4 mg/kg	22
Extension-Losartan Potassium	75

Laboratory Adverse Event

Group	Value	95% CI
Base Study-Losartan Potassium 0.1 mg/kg	1
Base Study-Losartan Potassium 0.3 mg/kg	1
Base Study-Losartan Potassium 0.7 mg/kg	0
Base Study-Losartan Potassium 1.4 mg/kg	0
Extension-Losartan Potassium	5

Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event Primary · up to 12 weeks (Base Study); up to 24 months (Extension)

Clinical Adverse Event

Group	Value	95% CI
Base Study-Losartan Potassium 0.1 mg/kg	0
Base Study-Losartan Potassium 0.3 mg/kg	0
Base Study-Losartan Potassium 0.7 mg/kg	0
Base Study-Losartan Potassium 1.4 mg/kg	0
Extension-Losartan Potassium	1

Laboratory Adverse Event

Group	Value	95% CI
Base Study-Losartan Potassium 0.1 mg/kg	0
Base Study-Losartan Potassium 0.3 mg/kg	0
Base Study-Losartan Potassium 0.7 mg/kg	0
Base Study-Losartan Potassium 1.4 mg/kg	0
Extension-Losartan Potassium	0

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 12 weeks (Base Study); up to 24 months (Extension). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Base Study-Losartan Potassium 0.1 mg/kg/Day

Serious: 3/34 (9%)

Deaths: —

Base Study-Losartan Potassium 0.3 mg/kg/Day

Serious: 2/54 (4%)

Deaths: —

Base Study-Losartan Potassium 0.7 mg/kg/Day

Serious: 2/63 (3%)

Deaths: —

Base Study-Losartan 1.4 mg/kg/Day

Serious: 0/33 (0%)

Deaths: —

Extension-Losartan 0.1 mg/kg/Day

Serious: 3/15 (20%)

Deaths: —

Extension-Losartan 0.3 mg/kg/Day

Serious: 5/28 (18%)

Deaths: —

Extension-Losartan 0.7 mg/kg/Day

Serious: 2/31 (6%)

Deaths: —

Extension-Losartan 1.4 mg/kg/Day

Serious: 5/42 (12%)

Deaths: —

Serious adverse events (28 terms)

Reaction	System	Base Study-Losartan Potass…	Base Study-Losartan Potass…	Base Study-Losartan Potass…	Base Study-Losartan 1.4 mg…	Extension-Losartan 0.1 mg/…	Extension-Losartan 0.3 mg/…	Extension-Losartan 0.7 mg/…	Extension-Losartan 1.4 mg/…
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—
Adenoiditis	Infections and infestations	—	—	—	—	—	—	—	—
Bronchopneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Conjunctivitis bacterial	Infections and infestations	—	—	—	—	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—	—	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—	—	—	—	—	—
Salmonellosis	Infections and infestations	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Upper respiratory tract infection bacterial	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Toxicity to various agents	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Metabolic acidosis	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Nephroblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Psychomotor retardation	Psychiatric disorders	—	—	—	—	—	—	—	—
Renal failure acute	Renal and urinary disorders	—	—	—	—	—	—	—	—

Other adverse events (42 terms — click to expand)

Reaction	System	Base Study-Losartan Potass…	Base Study-Losartan Potass…	Base Study-Losartan Potass…	Base Study-Losartan 1.4 mg…	Extension-Losartan 0.1 mg/…	Extension-Losartan 0.3 mg/…	Extension-Losartan 0.7 mg/…	Extension-Losartan 1.4 mg/…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Conjunctivitis	Eye disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Acute tonsillitis	Infections and infestations	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—	—	—	—	—
Impetigo	Infections and infestations	—	—	—	—	—	—	—	—
Otitis media acute	Infections and infestations	—	—	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—	—	—	—	—
Animal bite	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Protein urine present	Investigations	—	—	—	—	—	—	—	—
Red blood cell count decreased	Investigations	—	—	—	—	—	—	—	—
Urine leukocyte esterase positive	Investigations	—	—	—	—	—	—	—	—
White blood cells urine positive	Investigations	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—	—	—
Acute sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—	—	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—
Lip and/or oral cavity cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Enuresis	Renal and urinary disorders	—	—	—	—	—	—	—	—
Nephrocalcinosis	Renal and urinary disorders	—	—	—	—	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Gastroenteritis, Enteritis, Gastritis, Asthenia, Adenoiditis, Bronchopneumonia, Conjunctivitis bacterial, Laryngitis.

Data from ClinicalTrials.gov NCT00756938 adverse events section.

Sponsor's own description

This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized, open-label, dose-response study of losartan in hypertensive children.
   Webb NJ, Wells TG, Shahinfar S, Massaad R, et al · · 2014 · cited 14× · PMID 24875194 · DOI 10.2215/cjn.11111113