Olmesartan Pediatric Pharmacokinetic (PK) Study

An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Olmesartan medoxomil

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States
  • California
    • La Jolla, California, United States
  • Kentucky
    • Louisville, Kentucky, United States
  • Missouri
    • Kansas City, Missouri, United States
  • Ohio
    • Cleveland, Ohio, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olmesartan; 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.	Drug: Olmesartan medoxomil; Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Constant Rate	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Foe Olmesartan, the Time of Maximum Plasma Concentration	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Half-life of the Drug in Plasma	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Clearance	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Volume of Distribution	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Publications and helpful links

General Publications

• Wells TG, Blowey DL, Sullivan JE, Blumer J, Sherbotie JR, Song S, Rohatagi S, Heyrman R, Salazar DE. Pharmacokinetics of olmesartan medoxomil in pediatric patients with hypertension. Paediatr Drugs. 2012 Dec 1;14(6):401-9. doi: 10.2165/11631450-000000000-00000.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 9, 2005

Study Record Updates

• Last Update Posted (Estimate): April 15, 2010
• Last Update Submitted That Met QC Criteria: April 12, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Olmesartan PK in children
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Olmesartan; Olmesartan Medoxomil
• Other Study ID Numbers: CS0866-A-U102