None listed
Conditions
Interventions
Cohort A Type of group
Period I: Drug washing for 1 week
Period II: Treatment with OLMESARTAN MEDOXOMIL for 2 weeks. If the patient has less than 35 kg of weight, he will receive a low dose of 2.5 or 5 mg every day. If the patient weighs more than 35 kg they will receive 20 or 40 mg each day
Period III: Period of Discontinuation for 2 weeks. During this period, a group of patients will continue with the phase II medication and others will start with placebo
Period IV: Open treatment with OLMESARTAN MEDOXOMIL
Period I: Washing of medications for 1 week.
Period II: Treatment with OLMESARTAN MEDOXOMIL for 2 weeks. With a dose of 0.3 mg / kg
Period III: Discontinuation period for 2 weeks. During this period, a group of patients will continue with the phase II medication and others will start with placebo
Period IV: Open treatment with OLMESARTAN MEDOXOMIL for 44 weeks. All patients will start with the investigational drug at a dose of 10.3 mg / kg, the dose will increase to 0.6 mg / kg if the T
Sponsors
SANKYO PHARMA DEVELOPMENT,
Eligibility
Inclusion criteria
Inclusion criteria: PATIENTS BETWEEN 6 AND 16 YEARS OLD 1) Provide informed consent and agree to attend all visits 2) The patient agrees to participate in the study. 3) Female or male patient whose age is> 6 to 20 kg. 4) Adolescents taking oral contraceptives must have been under this therapy for at least 3 months. 5) Post-menarchal women should have a negative result on the pregnancy test 6) Hypertension, as defined by a TASps that is equal to or greater than the 95th percentile 7) Negative results in the analyzes of hepatitis B and C and negative result for the analysis of antibodies against HIV. 8) The patient is not a smoker, or has not smoked during the previous month. PATIENTS BETWEEN 1 AND 5 YEARS 1) Provide informed consent and agree to attend all visits 2) Female or male patient whose age is> I year to 5 kg. 3) Hypertension, as defined by a TASps that is equal to or greater than the 95th percentile 4) Negative results in the analyzes of hepatitis B and C and negative result for the analysis of antibodies against HIV. 5) The patient must not be a smoker.
Exclusion criteria
Exclusion criteria: 1) Any unstable medical condition or clinically significant chronic disease. 2) Significant clinical illness within the previous 10 days. 3) Clinically significant abnormality of the liver system or history of malabsorption or gastrointestinal surgery 4) Any of the following clinical laboratory abnormalities: AST / SGOT or ALT / SGPT> twice the maximum range limit, total bilirubin or direct bilimibin> twice the maximum limit, creatinine clearance maximum limit and serum albumin <2.5g / dL. 5) Known hypersensitivity to olmesartan medoxomil or its excipients 6) The patient has taken a research drug or participated in a research study within 30 days. 7) The patient is taking the excluded medications identified in Appendix 8. 8) Consumption of more than 180 mg of caffeine per day and / or the patient can not or does not want to abstain from drinking drinks containing caffeine or xanthine 9) Malignant hypertension 10) Any condition or reason that causes the investigator to believe that the patient is not suitable for the study. 11) The patient requires treatment for hypertension with more than 2 medications. 12) History of congestive heart failure, obstructive valvular disease or cardiomyopathy. 13) Coarctation of the uncorrected aorta, stenosis of the bilateral renal artery or stenosis of the unilateral renal artery in a solitary kidney. 14) Kidney transplant within the last 6 months or the patient is not on a stable therapy for rejection for at least 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change of the base percentile of the Systolic Blood Pressure (TASps): Measurements of Blood Pressure during period II (Period of response to the dose). Measure:Efficacy of Olemsartan medoxomil: Change in the TASps with the valley concentration from the baseline of the study. Timepoints:Day 1 and weeks 1, 2 and 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Analysis of serum chemistry and other tests considered relevant. Measure:Security of OLMESARTAN MEDOXOMIL Timepoints:Clinical evaluation in each of the 16 visits: Sem 1, 2, 3, 5, 7, 9, 11, 15,19, 23, 27,31, 35, 39, 43. Laboratory analysis: At the end of Phase II and Phase IV ; Outcome name:Change of the base percentile of the Systolic Blood Pressure (TASps) and in the Diastolic Blood Pressure (TADps): Measurements of Blood Pressure during period II (Period of response to the dose) and during period III (Period of randomized discontinuation) . Measure:Difference in the TASps between the values of the valley concentration at the end of Period II and at the end of Period III for patients treated with olmesartan, in comparison with the patients treated with placebo.Change from the baseline of the study in the TADsp , with valley concentration until the end of Period II. Difference in the TADsp between values of the valley concentration at the end of Period II until the end of Period III for patients treated with olmesartan, compared with patients with discontinuation of olmesartan medoxomil. Timepoints:Phase II: Day 1 and weeks 1, 2 and 3. Phase III: Weeks 4 and 5. ; Outcome name:Serum measurement of drug concentration during period II. Measure:Pharmacokinetics: Concentration of olmesartan medoxomil. Timepoints:In week 2, only one sample will be taken in one of the patient s randomized time intervals: 2-4 hours, 6-8 hours or 8-10 hours post-dose. In week 3 of Period II, a sample will be drawn with the valley concentration and a second sample will be taken 1-3 hours post dose. | — |
Countries
Argentina, Brazil, Chile, Colombia, India, Kenya, Peru, South Africa, Uganda, United States, Zambia
Outcome results
None listed