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

This study has been terminated.
(Achieving site readiness and enrolling the trial within a reasonable time)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00447603
First received: March 14, 2007
Last updated: March 12, 2014
Last verified: March 2014
  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: Placebo for Losartan
Drug: Placebo for Losartan/HCTZ
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Losartan 50 mg
Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Drug: losartan potassium
Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
Other Name: MK0954
Drug: Placebo for Losartan/HCTZ
losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Active Comparator: Losartan 100 mg
Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Drug: losartan potassium
Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
Other Name: MK0954
Drug: Placebo for Losartan/HCTZ
losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Experimental: Losartan 50 mg/HCTZ 12.5 mg
Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
Drug: hydrochlorothiazide (+) losartan potassium
losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
Other Name: MK0954A
Drug: Placebo for Losartan
Experimental: Losartan 100 mg/HCTZ 12.5 mg
Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
Drug: hydrochlorothiazide (+) losartan potassium
losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
Other Name: MK0954A
Drug: Placebo for Losartan

Detailed Description:

Participants who meet eligibility requirements will enter the single-blind Filter Period. Participants with either sitting systolic blood pressure (SiSBP) or sitting diastolic blood pressure (SiDBP) >=95th percentile for gender/age/height will be administered either losartan 25 mg or losartan 50 mg depending on body weight (<50 kg and >=50 kg, respectively). After 3 weeks, if SiSBP or SiDBP is >=95th percentile, participants will titrate to either losartan 50 mg or 100 mg according to weight. Participants with both SiSBP and SiDBP <95th percentile will be excluded from the study. After an additional 3 weeks, participants whose blood pressure (either SiSBP or SiDBP) remains >=95th percentile will then enter the double-blind phase. Participants who meet all entry criteria will be randomized in a 1:1 fashion to either losartan or losartan/hydrochlorothiazide (HCTZ) for 4 weeks and will be stratified according to body weight (<50 kg and >=50 kg). Participants whose weight is <50 kg will be randomized to losartan 50 mg or losartan50 mg/HCTZ 12.5 mg. Participants weighing >=50 kg will be randomized to losartan 100 mg or losartan/HCTZ 100 mg/12.5 mg. At the end of double-blind treatment, participants may enter a 20-week double-blind extension and will continue on their randomized therapy with losartan or losartan/HCTZ.

40 participants were enrolled and screened; the trial was terminated before any participants were randomized into the double-blind treatment 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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00447603     History of Changes
Other Study ID Numbers: 0954A-327, 2007_502
Study First Received: March 14, 2007
Results First Received: January 23, 2014
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 16, 2014