Olmesartan Pediatric Pharmacokinetic (PK) Study

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00151814
First received: September 8, 2005
Last updated: April 12, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Olmesartan medoxomil
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Michael Melino, PhD, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00151814     History of Changes
Other Study ID Numbers: CS0866-A-U102
Study First Received: September 8, 2005
Results First Received: March 19, 2010
Last Updated: April 12, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014