HypertensionPhase 2NCT02242344
Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension
A Phase 2 study testing Telmisartan in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to assess the blood pressure lowering effects of two doses of telmisartan over a four-week treatment period; to determine potentially effective doses for pediatric patients for future studies; to assess the safety and tolerability of two doses of telmisartan. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Sep 2007
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children and adolescents 6 to <18 years of age at time of informed consent/assent
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local Institutional Review Boards (IRBs), and/or patient assent, when appropriate
- Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)
- Weight ≥20 kg and ≤120 kg
- Hypertensive patients: in-clinic seated SBP ≥ 95th percentile based on age, height, and gender as defined in The Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents
- Ability to swallow whole tablets
Who cannot join
- Hypertension accompanied by symptoms or signs of central nervous system injury, including stroke, seizures, or encephalopathy, within 6 months prior to enrollment in the study
- Children whose in-clinic seated BP measurements are 20 mmHg SBP or 10 mmHg DBP above the 95th percentile based on The Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents
- Bilateral renal artery stenosis, unilateral renal artery stenosis in a solitary kidney, or uncorrected coarctation of the aorta
- Congestive heart failure, valvular disease, or clinically significant cardiac rhythm disturbances
- Bone marrow transplantation
- Solid organ transplantation
Show all 36Show fewer
- Stroke
- Chronic Kidney Disease with Glomerular Filtration Rate (GFR) to < 40 ml/min/1.73m2 by the Schwartz formula:
- Estimated GFR = (k x Height [cm]/ Serum Creatinine (mg/dL). k = 0.55 for all females and boys <13 years old; k = 0.7 in adolescent males ≥13 years old)
- Clinically significant hepatic disease or abnormal liver function tests:
- Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT), Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT), or Gamma-Glutamyl-Transferase (GGT) more than 2x upper limit of normal
- Total or direct bilirubin more than 1.5x upper limit of normal
- Clinically significant gastrointestinal disease that may affect drug absorption or excretion (including gastroesophageal reflux, malabsorption, biliary disease, pancreatic disease)
- Hyponatremia (serum sodium ≤130 mEq/L), hyperkalemia (Serum potassium ≥ 5.5 mEq/L), or other clinically significant electrolyte disorders
- Significant hypoalbuminemia (serum albumin ≤2.5 g/dL)
- Clinically significant neurological, psychiatric, pulmonary, hematological, or other condition that, in the opinion of the Investigator, will interfere with the safe and successful completion of the study
- Hypersensitivity to angiotensin II receptor antagonists
- Females who are of childbearing potential who:
- are pregnant/have a positive urine pregnancy test (UPT) prior to randomization (Visit 2), or
- are nursing, or lactating, or
- would not confirm abstinence (patients must be abstinent throughout the duration of the trial), or
- are not currently practicing one of the acceptable methods of birth control. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable or injectable contraceptives and estrogen patch.
- Concomitant therapy with any of the following agents:
- Any angiotensin II receptor antagonist within four (4) weeks prior to randomization into the study
- Any medication that could affect BP
- Angiotensin Converting Enzyme (ACE) inhibitors within four (4) weeks prior to randomization into the study
- Intravenous pulse steroid therapy within one month, daily treatment with oral corticosteroids ≥1 mg/kg/day)
- Anticonvulsant medications
- Bile acid binding agents
- Any drug that may interfere with absorption of the study medication (e.g.antacids)
- Drugs that may affect gastrointestinal motility (e.g. metoclopramide)
- Cytotoxic agents within 12 months prior to enrollment into the study
- Other investigational drugs or treatments within 30 days prior to enrollment
- Patients who require two or more anti-hypertensive medications
- Hereditary fructose intolerance
- Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension After Four Weeks of Treatment
Study to assess the blood pressure lowering effects of two doses of telmisartan over a four-week treatment period; to determine potentially effective doses for pediatric patients for future studies; to assess the safety and tolerability of two doses of telmisartan.
Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of telmisartan in children and adolescents aged 6 to <18 years, and to determine if age-related differences exist
- Conditions
- Hypertension
- Being tested
- Telmisartan, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| telmisartan - low dose | Experimental | Not described Receives: Drug: Telmisartan |
| telmisartan - high dose | Experimental | Not described Receives: Drug: Telmisartan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in seated systolic blood pressure (SBP)
Measured: Baseline, after 4 weeks of treatment
Secondary outcomes (14)
Change from baseline in seated diastolic blood pressure (DBP)
Measured: Baseline, after 4 weeks of treatment
Response rate of blood pressure
defined as both SBP and DBP < 95th percentile at the patient's final visit based on age, height, and gender
Measured: after 4 weeks
Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)
Measured: 72 hours after last study drug administration
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Measured: 72 hours after last study drug administration
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Measured: 72 hours after last study drug administration
Cavg (Average concentration of the analyte in plasma at steady state)
Measured: 72 hours after last study drug administration
tmax,ss (time from dosing to maximum concentration at steady state)
Measured: 72 hours after last study drug administration
AUCτ,ss (area under the concentration time curve of the analyte in plasma at steady state over a uniform dosing interval)
Measured: 72 hours after last study drug administration
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: 72 hours after last study drug administration
MRTpo,ss (mean residence time of the analyte in the body at steady state)
Measured: 72 hours after last study drug administration
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Measured: 72 hours after last study drug administration
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Measured: 72 hours after last study drug administration
PTF (peak trough fluctuation)
Measured: 72 hours after last study drug administration
Number of patients with adverse events
Measured: up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startApr 2006
- Primary completionSep 2007
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 Boehringer IngelheimThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242344
- Sponsor's protocol ID
- 502.403
- Status last verified
- Dec 2017
- First submitted
- 16 Sep 2014
- Last updated
- 28 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled, Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension After Four Weeks of Treatment
- ClinicalTrials.gov ID
- NCT02242344
- Acronym / sponsor ID
- 502.403
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Sep 2007 (actual)
- First posted
- 17 Sep 2014 (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.
Study to assess the blood pressure lowering effects of two doses of telmisartan over a four-week treatment period; to determine potentially effective doses for pediatric patients for future studies; to assess the safety and tolerability of two doses of telmisartan.
Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of telmisartan in children and adolescents aged 6 to <18 years, and to determine if age-related differences exist
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| telmisartan - low dose | Experimental | Drug: Telmisartan |
| telmisartan - high dose | Experimental | Drug: Telmisartan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female children and adolescents 6 to <18 years of age at time of informed consent/assent
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local Institutional Review Boards (IRBs), and/or patient assent, when appropriate
- Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)
- Weight ≥20 kg and ≤120 kg
- Hypertensive patients: in-clinic seated SBP ≥ 95th percentile based on age, height, and gender as defined in The Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents
Key exclusion criteria (36 listed)
- Hypertension accompanied by symptoms or signs of central nervous system injury, including stroke, seizures, or encephalopathy, within 6 months prior to enrollment in the study
- Children whose in-clinic seated BP measurements are 20 mmHg SBP or 10 mmHg DBP above the 95th percentile based on The Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents
- Bilateral renal artery stenosis, unilateral renal artery stenosis in a solitary kidney, or uncorrected coarctation of the aorta
- Congestive heart failure, valvular disease, or clinically significant cardiac rhythm disturbances
- Bone marrow transplantation
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 |
|---|---|---|
| Telmisartan | Drug | telmisartan - high dose, telmisartan - low dose |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in seated systolic blood pressure (SBP)
Time frame: Baseline, after 4 weeks of treatment
14 secondary outcomes
Change from baseline in seated diastolic blood pressure (DBP)
Time frame: Baseline, after 4 weeks of treatment
Response rate of blood pressure
Time frame: after 4 weeks
Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: 72 hours after last study drug administration
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: 72 hours after last study drug administration
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: 72 hours after last study drug administration
Cavg (Average concentration of the analyte in plasma at steady state)
Time frame: 72 hours after last study drug administration
tmax,ss (time from dosing to maximum concentration at steady state)
Time frame: 72 hours after last study drug administration
AUCτ,ss (area under the concentration time curve of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: 72 hours after last study drug administration
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: 72 hours after last study drug administration
MRTpo,ss (mean residence time of the analyte in the body at steady state)
Time frame: 72 hours after last study drug administration
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: 72 hours after last study drug administration
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Time frame: 72 hours after last study drug administration
PTF (peak trough fluctuation)
Time frame: 72 hours after last study drug administration
Number of patients with adverse events
Time frame: up to 45 days
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 28 Dec 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telmisartan in people with Hypertension, run by Boehringer Ingelheim.
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 36 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 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Change from baseline in seated systolic blood pressure (SBP) (time frame: Baseline, after 4 weeks of treatment). 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 28 Dec 2017.