A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)

Not Applicable

• Conditions: -I10 Essential (primary) hypertension; Essential (primary) hypertension; I10

• Registration Number: PER-026-07
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a) The patient is male or female and is between 6 and 17 years of age.
b) The patient presents an essential hypertension with a SiSBP or
SiDBP> 95th percentile but both SiSBP and SiDBP are <99th percentile + 5 mm Hg for their age / sex / height.
c) The patient can take tablets.
d) The parent or guardian has provided informed consent for their child to participate in the study. The patient´s consent will be obtained as required by local regulations.
e) Patients should have a glomerular filtration rate ≥ 30 mL / min / 1.73 m2.

Exclusion Criteria

a) The patient has a history of secondary hypertension of any etiology.
b) The patient is pregnant or is breastfeeding.
c) The patient has a history of severe or symptomatic hypertension within a period of 1 year before Visit 1.
d) The patient has a history of heart failure, hemodynamically significant obstructive valvular disease, or cardiomyopathy.
e) The patient has a clinically significant neurological, respiratory, gastrointestinal, hepatobiliary or hematologic disease.
f) The patient has a known history of coarctation of the uncorrected aorta, bilateral renal artery stenosis, or renal artery stenosis in a single kidney.
g) The patient has undergone a major organ transplant.
h) The patient has clinically significant laboratory values ​​outside the established normal range.
i) The patient has a history of clinically significant rhythm disorders.
j) The patient has a known sensitivity to losartan or another angiotensin II blocker, HCTZ, or a history of angioedema.
k) The patient who probably does not stick to the study procedures, does not keep appointments, or is planning to move during
the study.
I) The patient has any other factor that limits their participation.
m) The patient has participated in another clinical trial within the last 28 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified