Olmesartan Pediatric Pharmacokinetic (PK) Study

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Olmesartan medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151814

CS0866-A-U102

Details and patient eligibility

About

Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years

Enrollment: 24 patients

Sex: All

Ages: 12 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 12 months to 16 years inclusive
• Signed parental/guardian informed consent and assent from the subject
• Current treatment for hypertension, or, if not currently treated for hypertension, systolic blood pressure (SBP) greater than or equal to 95th percentile for gender and height-for-age, or, if not currently treated for hypertension, systolic blood pressure or diastolic blood pressure greater than or equal to 90th percentile for gender and height-for-age and diabetic or having a family history of hypertension
• Glomerular filtration rate (GFR) greater than or equal to 30 mL/min/1.73 m2, estimated using the Schwartz equation
• Sexually active females of child-bearing potential must be practicing an acceptable method of birth control
• Negative serum beta-human chorionic gonadotropin at screening and at admission (female of child-bearing potential only)

Exclusion criteria

• Clinically significant cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder
• History of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings within 1 year prior to screening
• Current treatment with more than 2 antihypertensive medications
• Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
• Serum albumin < 2.5 g/dL
• Major organ or bone marrow transplantation except for prior kidney transplantation of at least 6 months and with stable renal function meeting the inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Olmesartan

Experimental group

Description:

Children less than 6 years old received 0.3 mg/kg. Children 6 years old or older received 40 mg, if they weighed 35 kg or more; 20 mg if they weighed less than 35 kg.

Treatment:

Drug: Olmesartan medoxomil