Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension

December 27, 2017 updated by: Boehringer Ingelheim

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female children and adolescents 6 to <18 years of age at time of informed consent/assent
  2. 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
  3. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)
  4. Weight ≥20 kg and ≤120 kg
  5. 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
  6. Ability to swallow whole tablets

Exclusion Criteria:

  1. 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
  2. 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
  3. Bilateral renal artery stenosis, unilateral renal artery stenosis in a solitary kidney, or uncorrected coarctation of the aorta
  4. Congestive heart failure, valvular disease, or clinically significant cardiac rhythm disturbances
  5. Bone marrow transplantation
  6. Solid organ transplantation
  7. Stroke

  8. 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)

  9. Clinically significant hepatic disease or abnormal liver function tests:

    1. 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
    2. Total or direct bilirubin more than 1.5x upper limit of normal
  10. Clinically significant gastrointestinal disease that may affect drug absorption or excretion (including gastroesophageal reflux, malabsorption, biliary disease, pancreatic disease)
  11. Hyponatremia (serum sodium ≤130 mEq/L), hyperkalemia (Serum potassium ≥ 5.5 mEq/L), or other clinically significant electrolyte disorders
  12. Significant hypoalbuminemia (serum albumin ≤2.5 g/dL)
  13. 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
  14. Hypersensitivity to angiotensin II receptor antagonists

  15. Females who are of childbearing potential who:

    1. are pregnant/have a positive urine pregnancy test (UPT) prior to randomization (Visit 2), or
    2. are nursing, or lactating, or
    3. would not confirm abstinence (patients must be abstinent throughout the duration of the trial), or
    4. 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.

  16. 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
  17. Other investigational drugs or treatments within 30 days prior to enrollment
  18. Patients who require two or more anti-hypertensive medications
  19. Hereditary fructose intolerance
  20. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Experimental: telmisartan - low dose
Drug: Telmisartan
Experimental: telmisartan - high dose
Drug: Telmisartan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in seated systolic blood pressure (SBP)
Time Frame: Baseline, after 4 weeks of treatment
Baseline, after 4 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in seated diastolic blood pressure (DBP)
Time Frame: Baseline, after 4 weeks of treatment
Baseline, after 4 weeks of treatment
Response rate of blood pressure
Time Frame: after 4 weeks
defined as both SBP and DBP < 95th percentile at the patient's final visit based on age, height, and gender
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
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
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
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
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
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
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
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
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
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
72 hours after last study drug administration
PTF (peak trough fluctuation)
Time Frame: 72 hours after last study drug administration
72 hours after last study drug administration
Number of patients with adverse events
Time Frame: up to 45 days
up to 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 502.403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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