Cozaar XQ Re-examination Study (MK-0954-349)

This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of COZAAR XQ through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant with essential hypertension
Participant who is treated with COZAAR XQ within local label for the first time

Exclusion criteria

Participant who is treated with COZAAR XQ before contract and out of enrollment period
Participant who has a contraindication to COZAAR XQ according to the local label

Treatment and study plan

amlodipine/losartan

Drug

amlodipine/losartan (COZAAR XQ) prescribed according to the current local label

Other names: COZAAR XQ

Primary outcomes

Number of participants with any adverse experience

Time frame: Up to 14 days after last treatment
Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator

Time frame: At 8 weeks after first treatment

Secondary outcomes

Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator

Time frame: At 24 weeks after first treatment

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of COZAAR XQ in Usual Practice

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Jan 1, 2010
Registry last updated: Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed