307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects

Study identifier:D4020C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® (metoprolol succinate) Extended-release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Open-Label Extension of Protocol 307A

Medical condition

hypertension

Phase

Phase 3

Healthy volunteers

No

Study drug

metoprolol succinate

Sex

All

Actual Enrollment

100

Study type

Interventional

Age

6 Years - 16 Years

Date

Study Start Date: 01 Jul 2002
Primary Completion Date: -
Study Completion Date: -

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2006 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria