Status:
COMPLETED
Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief 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; t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT02242344
Start Date
April 1 2006
Last Update
December 28 2017
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