A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00447603

Purpose

The purpose of this study is to test the safety and effectiveness of Losartan as compared to Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.

Condition	Intervention	Phase
Hypertension	Drug: hydrochlorothiazide (+) losartan potassium Drug: losartan potassium Drug: Comparator: losartan potassium Drug: Comparator: Placebo (unspecified)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium Potassium chloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Lower blood pressure [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Well tolerated in pediatric patients. [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	April 2007
Estimated Study Completion Date:	November 2007
Estimated Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Comparator: losartan potassium losartan potassium 25mg titrating up to Losartan 50mg tablet po qd for a 4 week study period. Drug: Comparator: Placebo (unspecified) losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
2	Drug: losartan potassium Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period Drug: Comparator: Placebo (unspecified) losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
3	Drug: hydrochlorothiazide (+) losartan potassium losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period. Drug: Comparator: losartan potassium losartan potassium 25mg titrating up to Losartan 50mg tablet po qd for a 4 week study period. Drug: Comparator: Placebo (unspecified) losartan potassium 25mg Pbo tablet po qd; 50mg Pbo tablet po qd; 100mg Pbo tablet po qd; for a 4 week study period.
4	Drug: hydrochlorothiazide (+) losartan potassium losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period. Drug: losartan potassium Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period Drug: Comparator: Placebo (unspecified) losartan potassium 25mg Pbo tablet po qd; 50mg Pbo tablet po qd; 100mg Pbo tablet po qd; for a 4 week study period.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is male/female and 6 to 17 years of age at the time of study with hypertension (high blood pressure)
Patient is able to swallow tablets
Females of child bearing potential must use acceptable contraception throughout the trial

Exclusion Criteria:

Patient has a history of heart, metabolic or kidney disease
Patient has a history of known heart, lung, liver and other body system disorders
Patient is pregnant or nursing
Patient has participated in another clinical trial within the last 28 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447603

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_502, MK0954A-327
Study First Received:	March 14, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00447603 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Losartan
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on November 22, 2009