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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: amlodipine/losartan (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome:

Number of participants with any adverse experience

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: February 2010
Last updated: April 9, 2015

Page last updated: August 20, 2015

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