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Register:	EUCTR
Last refreshed on:	30 June 2019
Main ID:	EUCTR2007-000690-34-FI
Date of registration:	16/04/2007
Prospective Registration:	Yes
Primary sponsor:	MSD Finland Oy
Public title:	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
Scientific title:	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:	29/05/2007
Target sample size:	300
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000690-34
Study type:	Interventional clinical trial of medicinal product
Study design:	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
Phase:	Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV):

Countries of recruitment
Estonia	Finland	Germany	Hungary	Lithuania	United Kingdom

Contacts

Name:
Address:
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Email:
Affiliation:

Name:
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Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Essential Hypertension
MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension

Intervention(s)

Trade Name: losartan potassium-hydrochlorothiazide
50-12.5: HYZAAR
100-12.5: COZAAR PLUS 100/12.5
Pharmaceutical Form: Tablet
INN or Proposed INN: Losartan Potassium and Hydrochlorothiazide
Current Sponsor code: MK-0954A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-12.5;100-12.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: COZAAR
Pharmaceutical Form: Tablet
Current Sponsor code: MK-0954
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25,50, and 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

Primary end point(s): Change in mean trough SiSBP

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.

Secondary Outcome(s)

Secondary ID(s)

2007-000690-34-EE

0954A-327

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:	16/04/2016
Date Completed:	22/10/2007
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-000690-34/results

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