A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)
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ClinicalTrials.gov Identifier: NCT00447603 |
Recruitment Status :
Terminated
(Achieving site readiness and enrolling the trial within a reasonable time)
First Posted : March 15, 2007
Results First Posted : March 5, 2014
Last Update Posted : August 21, 2018
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Drug: hydrochlorothiazide (+) losartan potassium Drug: losartan potassium Drug: Placebo for Losartan Drug: Placebo for Losartan/HCTZ | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Actual Study Start Date : | May 24, 2007 |
Actual Primary Completion Date : | October 22, 2007 |
Actual Study Completion Date : | October 22, 2007 |

Arm | Intervention/treatment |
---|---|
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
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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 |
- Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period [ Time Frame: Baseline and Week 4 ]
- Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study [ Time Frame: up to 4 weeks ]
- 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 ]
- Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period [ Time Frame: Baseline and Week 4 ]

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447603
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Study Data/Documents: CSR Synopsis

Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00447603 History of Changes |
Other Study ID Numbers: |
0954A-327 2007_502 |
First Posted: | March 15, 2007 Key Record Dates |
Results First Posted: | March 5, 2014 |
Last Update Posted: | August 21, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
Additional relevant MeSH terms:
Hypertension Losartan Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers |
Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |