HypertensionPhase 2NCT00528827
A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension
A Phase 2 study testing Cardene® I.V. in people with Hypertension, run by Facet Biotech at 2 sites in United States.
Trial summary
To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Cardene® I.V.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Dec 2008
- Phase
- Phase 2
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Evidence of Stage 1 or Stage 2 systolic hypertension at the time of screening.
- Male or female subjects, ages ≥2 to ≤16 years.
- Females who meet either of the following criteria:
- Non-childbearing potential , as documented by:
- a medical history of non-menstruation or
- surgical sterility from oophorectomy and/or hysterectomy. * A history of tubal ligation or evidence of a sterile sexual partner is insufficient evidence of non-childbearing potential.
- Childbearing potential: provide a negative urine pregnancy test within 24 hours of administration of study drug and agree to utilize effective contraception or remain abstinent during the entire treatment and follow-up periods of the study.
- Signed informed consent provided by an authorized subject representative and assent from subject, if feasible (based on local Institutional Review Board (IRB)/ethics panel requirements).
Who cannot join
- Subjects with seizures, altered state of consciousness, chest pain, facial palsy or intracranial hemorrhage at the time of screening.
- Receiving antihypertensive medication within a duration specified prior to screening.
- Treatment with cimetidine within 10 hours prior to dosing with study drug.
- Any known or suspected allergy to nicardipine hydrochloride.
- A calculated Glomerular Filtration Rate (GFR) under 30 mL/min/ 1.73 m2 as calculated using the Schwartz formula and the associated K values.
- Known history of severe aortic stenosis.
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- Known history of severe left ventricular dysfunction.
- Known history of severely impaired hepatic function with portal hypertension.
- Liver function test (AST or ALT) results greater than or equal to twice the upper limit of normal.
- Receiving maintenance hemodialysis at screening or anticipated to require hemodialysis within 12 hours following initiation of treatment with study drug.
- Receiving a blood transfusion at screening or anticipated to require blood transfusions within 12 hours following initiation of treatment with study drug.
- Lack of appropriate intravenous (I.V.) access.
- Inability to tolerate a large-volume I.V. infusion.
- Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.
- Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Beverly Hills, California, 90211
Study site
Miami, Florida, 33145
About this study
To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension.
Read the detailed description
Children with acute hypertensive episodes are frequently treated with the same marketed drugs as adults. Few drugs are specifically indicated for use in children with severe hypertension. Cardene I.V. has been widely used in children with severe hypertension without specific dosing recommendations for children in the labeling. This study is designed to examine the pharmacokinetics, pharmacodynamics, safety, and efficacy of using Cardene I.V. to reduce blood pressure (BP) in children with hypertension and will provide important information to guide use in pediatric patients.
- Conditions
- Hypertension
- Being tested
- Cardene® I.V.
- Keywords
- Hypertension, High Blood Pressure, Pediatric Hypertension, High blood pressure 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.
Cardene® I.V.Drug
- 5 mcg/kg/min Cardene I.V.
- 2.5 mcg/kg/min Cardene I.V.
- 0.5 mcg/kg/min Cardene I.V.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Cardene® I.V. |
| 2 | Experimental | 5 mcg Receives: Drug: Cardene® I.V. |
| 3 | Experimental | 2.5 Receives: Drug: Cardene® I.V. |
| 4 | Experimental | 0.5 Receives: Drug: Cardene® I.V. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change in SBP (Systolic Blood Pressure) from baseline during the 30-minute Randomized, Placebo-controlled Infusion Phase for each dose level of Cardene I.V. compared to placebo.
Measured: 30 minutes
Secondary outcomes (1)
1) Mean percent change in SBP and DBP between various phases of dosing. 2) Proportion of subjects requiring additional antihypertensive medications during the treatment period. 3) Mean effective dose of Cardene I.V.
Measured: 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Due to the sale of Cardene IV, the sponsor has stopped enrollment and withdrawn the study. No safety issues were identified.
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Facet Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528827
- Sponsor's protocol ID
- Cardene® I.V. 1406
- Status last verified
- Mar 2012
- First submitted
- 10 Sep 2007
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension
- ClinicalTrials.gov ID
- NCT00528827
- Acronym / sponsor ID
- Cardene® I.V. 1406
- Conditions
- Hypertension
- Keywords
- Hypertension, High Blood Pressure, Pediatric Hypertension, High blood pressure in children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the sale of Cardene IV, the sponsor has stopped enrollment and withdrawn the study. No safety issues were identified.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Facet BiotechIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Sep 2007 (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.
To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension.
Detailed description
Children with acute hypertensive episodes are frequently treated with the same marketed drugs as adults. Few drugs are specifically indicated for use in children with severe hypertension. Cardene I.V. has been widely used in children with severe hypertension without specific dosing recommendations for children in the labeling. This study is designed to examine the pharmacokinetics, pharmacodynamics, safety, and efficacy of using Cardene I.V. to reduce blood pressure (BP) in children with hypertension and will provide important information to guide use in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Cardene® I.V. |
| 2 | Experimental | Drug: Cardene® I.V.5 mcg |
| 3 | Experimental | Drug: Cardene® I.V.2.5 |
| 4 | Experimental | Drug: Cardene® I.V.0.5 |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Evidence of Stage 1 or Stage 2 systolic hypertension at the time of screening.
- Male or female subjects, ages ≥2 to ≤16 years.
- Females who meet either of the following criteria:
- Signed informed consent provided by an authorized subject representative and assent from subject, if feasible (based on local Institutional Review Board (IRB)/ethics panel requirements).
Key exclusion criteria (15 listed)
- Subjects with seizures, altered state of consciousness, chest pain, facial palsy or intracranial hemorrhage at the time of screening.
- Receiving antihypertensive medication within a duration specified prior to screening.
- Treatment with cimetidine within 10 hours prior to dosing with study drug.
- Any known or suspected allergy to nicardipine hydrochloride.
- A calculated Glomerular Filtration Rate (GFR) under 30 mL/min/ 1.73 m2 as calculated using the Schwartz formula and the associated K values.
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 |
|---|---|---|
| Cardene® I.V.* 5 mcg/kg/min Cardene I.V. * 2.5 mcg/kg/min Cardene I.V. * 0.5 mcg/kg/min Cardene I.V. | Drug | 1, 2, 3, 4 |
Primary outcome
Mean percent change in SBP (Systolic Blood Pressure) from baseline during the 30-minute Randomized, Placebo-controlled Infusion Phase for each dose level of Cardene I.V. compared to placebo.
Time frame: 30 minutes
1 secondary outcome
1) Mean percent change in SBP and DBP between various phases of dosing. 2) Proportion of subjects requiring additional antihypertensive medications during the treatment period. 3) Mean effective dose of Cardene I.V.
Time frame: 72
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardene® I.V. in people with Hypertension, run by Facet Biotech at 2 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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 16 Mar 2012. 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 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Mean percent change in SBP (Systolic Blood Pressure) from baseline during the 30-minute Randomized, Placebo-controlled Infusion Phase for each dose level of Cardene I.V. compared to placebo. (time frame: 30 minutes). 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 16 Mar 2012.