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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 March 2020 |
Main ID: |
EUCTR2007-000690-34-DE |
Date of registration:
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07/05/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension
- Pediatric Hypertension Efficacy Study
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Scientific title:
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A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension
- Pediatric Hypertension Efficacy Study |
Date of first enrolment:
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03/08/2009 |
Target sample size:
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320 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000690-34 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Estonia
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Finland
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Germany
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Hungary
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Lithuania
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: Male or female and 6-17 years of age; essential hypertension(currently receiving antihypertensive therapy (= 2 medications) or trough SiSBP or SiDBP = 95th percentile and < 99th percentile + 5 mm Hg{Stage 1 HTN}); able to swallow tablets. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: Secondary hypertension (e.g. renal, CV, or endocrine cause of HTN); severe or symptomatic HTN within the past year; pregnancy or lactating; history of heart failure, hemodynamically significant obstructive valvular disease or cardiomyopathy; clinically significant neurologic, respiratory, gastrointestinal, hepatobiliary, or hematologic disease; organ transplantation; uncorrected coarctation of the aorta, bilateral renal artery stenosis, or renal artery stenosis to a single kidney
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Essential Hypertension MedDRA version: 9.1
Level: LLT
Classification code 10015488
Term: Essential hypertension
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Intervention(s)
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Trade Name: HYZAAR 50/12,5
Pharmaceutical Form: Film-coated tablet INN or Proposed INN: losartan potassium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: hydrochlorothiazide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12,5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: COZAAR Pharmaceutical Form: Film-coated tablet INN or Proposed INN: losartan potassium Current Sponsor code: MK-0954 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
Trade Name: COZAAR PLUS 100/12.5 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: losartan potassium Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: hydrochlorothiazide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12,5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: COZAAR Pharmaceutical Form: Film-coated tablet INN or Proposed INN: losartan potassium Current Sponsor code: MK-0954 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: COZAAR Pharmaceutical Form: Film-coated tablet INN or Proposed INN: losartan potassium Current Sponsor code: MK-0954 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To evaluate the antihypertensive efficacy (as assessed by change in mean trough SiSBP) after 4 weeks of treatment with losartan/HCTZ combination therapy in comparison with losartan monotherapy in pediatric patients (defined as children aged 6-17 years who have the ability to swallow tablets) with essential hypertension (defined as patients = the 95th percentile for SBP or DBP for gender/age/height) who are not adequately controlled following a 6-week single-blind losartan treatment (filter) period.
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Secondary Objective: To evaluate the antihypertensive efficacy (as assessed by change in mean trough SiDBP) of losartan/HCTZ combination therapy compared with losartan monotherapy in pediatric patients with essential hypertension following 4 weeks of treatment.
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Primary end point(s): Change in mean trough SiSBP
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Secondary ID(s)
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2007-000690-34-EE
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327-00
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 26/06/2007
Contact:
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