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

NCT00447603 | Terminated Phase 3 Results

• 2 other identifiers: 0954A-3272007_502
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period

  Baseline and Week 4

• Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study

  up to 4 weeks

• Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study

  up to 4 weeks

Secondary Outcomes (1)

• Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period

  Baseline and Week 4

Study Arms (4)

Losartan 50 mg

ACTIVE COMPARATOR

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; Drug: Placebo for Losartan/HCTZ

Losartan 100 mg

ACTIVE COMPARATOR

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; Drug: Placebo for Losartan/HCTZ

Losartan 50 mg/HCTZ 12.5 mg

EXPERIMENTAL

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; Drug: Placebo for Losartan

Losartan 100 mg/HCTZ 12.5 mg

EXPERIMENTAL

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; Drug: Placebo for Losartan

Interventions

hydrochlorothiazide (+) losartan potassium DRUG

losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.

Also known as: MK0954A

Losartan 100 mg/HCTZ 12.5 mg; Losartan 50 mg/HCTZ 12.5 mg

losartan potassium DRUG

Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period

Also known as: MK0954

Losartan 100 mg; Losartan 50 mg

Placebo for Losartan DRUG

Losartan 100 mg/HCTZ 12.5 mg; Losartan 50 mg/HCTZ 12.5 mg

Placebo for Losartan/HCTZ DRUG

losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.

Losartan 100 mg; Losartan 50 mg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combination; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Limitations and Caveats

The study was discontinued early (during screening) due to limited availability of sites and readiness of sites to enroll participants within the predefined time.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 15, 2007
• Study Start: May 24, 2007
• Primary Completion: October 22, 2007
• Study Completion: October 22, 2007
• Last Updated: June 18, 2024
• Results First Posted: March 5, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share