Cozaar XQ Re-examination Study (MK-0954-349)
Verified July 2014 by Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: December 31, 2009
Last updated: July 31, 2014
Last verified: July 2014
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.
||Time Perspective: Prospective
||Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of COZAAR XQ in Usual Practice
Primary Outcome Measures:
- Number of participants with any adverse experience [ Time Frame: Up to 14 days after last treatment ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Participants with hypertension treated with amlodipine/losartan(Cozaar XQ)
amlodipine/losartan (COZAAR XQ) prescribed according to the current local label
Other Name: COZAAR XQ
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Participants with essential hypertension not adequately controlled with amlodipine or losartan monotherapy; initial therapy for participants with stage 2 hypertension
- Participant with essential hypertension
- Participant who is treated with COZAAR XQ within local label for the first time
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041807
|Contact: Toll Free Number
|MSD Korea LTD
|Seoul, Korea, Republic of |
|Contact: Cem Ozesen 90 212 3361260 |
Merck Sharp & Dohme Corp.
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 31, 2009
||July 31, 2014
||Korea: Food and Drug Administration
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists