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

Hypertension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypertension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

All participantsParticipants with hypertension treated with amlodipine/losartan(Cozaar XQ)

Study Status

Completed

Start Date: February 2010

Completed Date: March 2015

Phase:

Type: Observational

Design:

Primary Outcome: Number of participants with any adverse experience

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

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor:

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01041807

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