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

Completed

• Conditions: Hypertension
• Interventions: Drug: amlodipine/losartan

• Registration Number: NCT01041807
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-31
• Study First Submitted QC: 2009-12-31
• Study First Posted: 2010-01-01
• Study Start: 2010-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 669

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	amlodipine/losartan	Participants with hypertension treated with amlodipine/losartan(Cozaar XQ)

Primary Outcome Measures

Name	Time	Method
Number of participants with any adverse experience	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	At 8 weeks after first treatment

Secondary Outcome Measures

Name	Time	Method
Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator	At 24 weeks after first treatment