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

NCT02242344 | Completed Phase 2

• 1 other identifier: 502.403
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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; 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in seated systolic blood pressure (SBP)

  Baseline, after 4 weeks of treatment

Secondary Outcomes (14)

• Change from baseline in seated diastolic blood pressure (DBP)

  Baseline, after 4 weeks of treatment

• Response rate of blood pressure

  after 4 weeks

• Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)

  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)

  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)

  72 hours after last study drug administration

Study Arms (3)

telmisartan - low dose

EXPERIMENTAL

Drug: Telmisartan

telmisartan - high dose

EXPERIMENTAL

Drug: Telmisartan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Telmisartan DRUG

telmisartan - high dose; telmisartan - low dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: April 1, 2006
• Primary Completion: September 1, 2007
• Last Updated: December 28, 2017

Record last verified: 2017-12