Skip to main content
OpenTrials
Completed

NCT Number: NCT00151814

Olmesartan Pediatric Pharmacokinetic (PK) Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

12 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil

Drug

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.

Primary outcomes

  1. For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  2. For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  3. For Olmesartan, the Elimination Constant Rate

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  4. For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  5. Foe Olmesartan, the Time of Maximum Plasma Concentration

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  6. For Olmesartan, the Elimination Half-life of the Drug in Plasma

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  7. For Olmesartan, the Apparent Oral Clearance

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  8. For Olmesartan, the Apparent Oral Volume of Distribution

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2005
Registry last updated
Apr 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.