HypertensionPhase 1NCT01447485
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
A Phase 1 study testing Valsartan (VAL489) in people with Hypertension and Chronic Kidney Disease, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Hypertension, Chronic Kidney Disease, Nephrotic Syndrome
- What is being tested?
- Valsartan (VAL489)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
Who cannot join
- GFR < 30 mL/min/1.73 m2
- Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
- Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
- Conditions
- Hypertension, Chronic Kidney Disease, Nephrotic Syndrome
- Being tested
- Valsartan (VAL489)
- Keywords
- Hypertension, chronic kidney disease, nephrotic syndrome, pharmacokinetics
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic, Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan (VAL489)Drug
| Study group | Role | What they receive |
|---|---|---|
| Valsartan 20 mg or 40 mg | Experimental | Not described Receives: Drug: Valsartan (VAL489) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of valsartan in plasma
Measured: Up to 24 hours post-dose
Cmax of valsartan in plasma
Measured: Up to 24 hours post-dose
Tmax of valsartan in plasma
Measured: Up to 24 hours post-dose
T1/2 of valsartan in plasma
Measured: Up to 24 hours post-dose
CL/F of valsartan in plasma
Measured: Up to 24 hours post-dose
Secondary outcomes (5)
ECG evaluations
Measured: 24 hours post-dose
Standard clinical laboratory evaluations
Measured: 24 hours post-dose
Vital signs
Measured: 2, 4, and 24 hours post-dose
Physical examination
Measured: 24 hours post-dose
Number and severity of adverse events
Measured: Up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447485
- Sponsor's protocol ID
- CVAL489K1101
- Status last verified
- May 2012
- First submitted
- 31 Aug 2011
- Last updated
- 21 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age
- ClinicalTrials.gov ID
- NCT01447485
- Acronym / sponsor ID
- CVAL489K1101
- Conditions
- Hypertension, Chronic Kidney Disease, Nephrotic Syndrome
- Keywords
- Hypertension, chronic kidney disease, nephrotic syndrome, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valsartan 20 mg or 40 mg | Experimental | Drug: Valsartan (VAL489) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
Key exclusion criteria (4 listed)
- GFR < 30 mL/min/1.73 m2
- Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
- Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Valsartan (VAL489) | Drug | Valsartan 20 mg or 40 mg |
Primary outcome
AUC of valsartan in plasma
Time frame: Up to 24 hours post-dose
Cmax of valsartan in plasma
Time frame: Up to 24 hours post-dose
Tmax of valsartan in plasma
Time frame: Up to 24 hours post-dose
T1/2 of valsartan in plasma
Time frame: Up to 24 hours post-dose
CL/F of valsartan in plasma
Time frame: Up to 24 hours post-dose
5 secondary outcomes
ECG evaluations
Time frame: 24 hours post-dose
Standard clinical laboratory evaluations
Time frame: 24 hours post-dose
Vital signs
Time frame: 2, 4, and 24 hours post-dose
Physical examination
Time frame: 24 hours post-dose
Number and severity of adverse events
Time frame: Up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Results for CVAL489K1101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 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 Valsartan (VAL489) in people with Hypertension and Chronic Kidney Disease, run by Novartis Pharmaceuticals at 2 sites in Japan.
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 1 inclusion and 4 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC of valsartan in plasma (time frame: Up to 24 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2020.