HypertensionPhase 1NCT00151814

Olmesartan Pediatric Pharmacokinetic (PK) Study

A Phase 1 study testing Olmesartan medoxomil in people with Hypertension, run by Daiichi Sankyo at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years Read more about this study

Who is it for?: Ages 12 months to 16 years
Conditions the study is for: Hypertension
What is being tested?: Olmesartan medoxomil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 5 sitesUnited States
Study dates: Sep 2005to Feb 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Study site
Cleveland, Ohio
Study site
Kansas City, Missouri
Study site
La Jolla, California
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky

Other trials in United States

About this study

Official title: 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

Conditions: Hypertension
Being tested: Olmesartan medoxomil
Keywords: Olmesartan PK in children
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olmesartan medoxomilDrug
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.

Study groups in NCT00151814
Study group	Role	What they receive
Olmesartan	Experimental	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. Receives: Drug: Olmesartan medoxomil

What is being measured

The primary outcome is the main question the study is designed to answer.

For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
Measured: 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
Measured: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Constant Rate
Measured: 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
Measured: 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
Measured: 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
Measured: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Clearance
Measured: 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
Measured: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Feb 2008

First posted9 Sep 2005 (estimated)
Study startSep 2005
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00151814
Sponsor's protocol ID: CS0866-A-U102
Status last verified: Apr 2010
First submitted: 8 Sep 2005
Last updated: 15 Apr 2010
Results posted: Yes, on ClinicalTrials.gov

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.
PubMed 22880942

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension
ClinicalTrials.gov ID: NCT00151814
Acronym / sponsor ID: CS0866-A-U102
Conditions: Hypertension
Keywords: Olmesartan PK in children
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 9 Sep 2005 (estimated)
Results: Posted 9 Apr 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Olmesartan	Experimental	Drug: Olmesartan medoxomilChildren 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.

Who may qualify

Ages: 12 months to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Olmesartan medoxomilChildren 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.	Drug	Olmesartan

Primary outcome

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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 9 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olmesartan Group - 2 to 5 Years Old	4	4
Olmesartan Group - 6 to 12 Years Old	10	10
Olmesartan Group - 13 to 16 Years Old	10	10

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL*hr

Measure	6-12 Years of Age Olmesartan Group n = 10	13-16 Years of Age Olmesartan Group n = 10
Value	7874 (2913)	5851 (2083)

Population analysed: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL*hr

Measure	6-12 Years of Age Olmesartan Group n = 10	13-16 Years of Age Olmesartan Group n = 10
Value	7988 (2913)	5982 (2130)

Population analysed: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.

Primary outcome: 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. Mean (Standard Deviation). Unit: L/hr

Measure	6-12 Years of Age Olmesartan Group n = 10	13-16 Years of Age Olmesartan Group n = 10
Value	0.090 (0.029)	0.079 (0.016)

Population analysed: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	6-12 Years of Age Olmesartan Group n = 10	13-16 Years of Age Olmesartan Group n = 10
Value	1227 (451)	895 (262)

Population analysed: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.

Adverse events

Time frame: <3 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olmesartan Group - 2 to 5 Years Old	0 of 4 (0%)	1 of 4 (25%)	Not reported
Olmesartan Group - 6 to 12 Years Old	0 of 10 (0%)	2 of 10 (20%)	Not reported
Olmesartan Group - 13 to 16 Years Old	0 of 10 (0%)	1 of 10 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22880942Wells 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.

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Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Olmesartan medoxomil in people with Hypertension, run by Daiichi Sankyo at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00151814, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2010.