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

March 14, 2007
March 12, 2014
May 2007
October 2007   (final data collection date for primary outcome measure)
  • 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 ]
Lower blood pressure after 4 weeks of treatment.
Complete list of historical versions of study NCT00447603 on ClinicalTrials.gov Archive Site
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 ]
Well tolerated in pediatric patients.
Not Provided
Not Provided
 
A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: hydrochlorothiazide (+) losartan potassium
    losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
    Other Name: MK0954A
  • 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
  • Drug: Placebo for Losartan/HCTZ
    losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
  • 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
    Interventions:
    • Drug: losartan potassium
    • Drug: Placebo for Losartan/HCTZ
  • 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
    Interventions:
    • Drug: losartan potassium
    • Drug: Placebo for Losartan/HCTZ
  • 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
    Interventions:
    • Drug: hydrochlorothiazide (+) losartan potassium
    • 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
    Interventions:
    • Drug: hydrochlorothiazide (+) losartan potassium
    • Drug: Placebo for Losartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00447603
0954A-327, 2007_502
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP