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Olmesartan Pediatric Pharmacokinetic (PK) Study
This study has been completed.
First Received: September 8, 2005   Last Updated: April 9, 2008   History of Changes
Sponsored by: Daiichi Sankyo Inc.
Information provided by: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00151814
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Olmesartan medoxomil
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title: An Open-Label Study of the Single-Dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: single-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Olmesartan medoxomil
    12-23 mo. old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children
  Eligibility

Ages Eligible for Study:   12 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 12 months to 16 years inclusive (AS OF MARCH 2007 ONLY SUBJECTS AGED 12 MONTHS TO 5 YEARS ARE BEING ACCEPTED)
  • Signed parental/guardian informed consent and assent from the subject
  • Current treatment for hypertension, OR, if not currently treated for hypertension, SBP or DBP greater than or equal to 95th percentile for gender and height-for-age, OR, if not currently treated for hypertension, SBP or DBP 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-HCG 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151814

Locations
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
La Jolla, California, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Ohio
Cleveland, Ohio, United States
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo ( Michael Melino, PhD )
Study ID Numbers: CS0866-A-U102
Study First Received: September 8, 2005
Last Updated: April 9, 2008
ClinicalTrials.gov Identifier: NCT00151814     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Olmesartan PK in children

Study placed in the following topic categories:
Angiotensin II Type 1 Receptor Blockers
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Hypertension

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on August 30, 2009