Olmesartan Pediatric Pharmacokinetic (PK) Study

• Conditions: Hypertension; MedDRA version: 18.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-003328-30-Outside-EU/EEA
• Lead Sponsor: Daiichi Sankyo Pharma Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-27
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Age 12 months to 16 years, inclusive
2.Signed parental/guardian informed consent provided and assent from the subject if he/she was = 7 years old, or as required by the local IRB.
3.Glomerular filtration rate (GFR) = 30 mL/min/1.73 m2, estimated using the Schwartz equation
4.Sexually active females of child-bearing potential must have been practicing an acceptable method of birth control as defined as oral, injectable, or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide.
5.Negative serum beta-hCG at Screening and at administration (females of child bearing potential only)
6.Hypertension defined as one of the following:
- Current treatment for hypertension
- Systolic blood pressure (SBP) = 95th percentile
- SBP or diastolic blood pressure (DBP) = 90th percentile if diabetic or with a family history of hypertension
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Clinically significant cardiac, gastrointestinal, hematological, hepatic or hepatobiliary, neurological, or pulmonary (except asthma) disorder
2.History of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurological findings within 2 years prior to Screening
3.Current treatment with more than 2 antihypertensive medications
4.Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
5.Serum albumin < 2.5 g/dL
6.Major organ or bone marrow transplantation except for kidney transplantation at least 6 months prior to Screening with stable renal function meeting the inclusion criteria
7.History of classic allergic response to the angiotensin II receptor antagonist class of drugs
8.Pregnancy or current lactation
9.Pertinent electrolyte disorders (serum sodium = 130 mEq/L, potassium = 5.5 mEq/L, for example)
10.Significant systemic disease that, in the judgment of the investigator, would disqualify the subject for this study
11.History of drug or alcohol abuse
12.Current treatment with any of the following medications: anticonvulsants, bile acid sequestrants, metoclopramide, major psychotropic agents, glucocorticosteroids (high-dose regimens, i.e., > 1 mg/kg given daily), prokinetic agents such as bethanechol or cisapride, antibiotics, except as approved by the Sponsor, any drug that might interfere with the absorption of OM
13.Any laboratory value at Screening outside the range of normal limits for the appropriate age group unless approved by the Principal Investigator and Sponsor
14.History of malignancy or exposure to cytotoxic agents within the last 6 months
15.Participation in another investigational new drug research study in the previous 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified