Cozaar XQ Re-examination Study (MK-0954-349)
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ClinicalTrials.gov Identifier: NCT01041807 |
Recruitment Status :
Completed
First Posted : January 1, 2010
Last Update Posted : February 15, 2022
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Sponsor:
Organon and Co
Information provided by (Responsible Party):
Organon and Co
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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.
Condition or disease | Intervention/treatment |
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Hypertension | Drug: amlodipine/losartan |
Study Type : | Observational |
Actual Enrollment : | 669 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of COZAAR XQ in Usual Practice |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Hypertension
Group/Cohort | Intervention/treatment |
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All participants
Participants with hypertension treated with amlodipine/losartan(Cozaar XQ)
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Drug: amlodipine/losartan
amlodipine/losartan (COZAAR XQ) prescribed according to the current local label
Other Name: COZAAR XQ |
Primary Outcome Measures :
- 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 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 ]
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Study Population
Participants with essential hypertension not adequately controlled with amlodipine or losartan monotherapy; initial therapy for participants with stage 2 hypertension
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
No Contacts or Locations Provided
Responsible Party: | Organon and Co |
ClinicalTrials.gov Identifier: | NCT01041807 |
Other Study ID Numbers: |
0954-349 2009_004 ( Other Identifier: Merck Registration Number ) |
First Posted: | January 1, 2010 Key Record Dates |
Last Update Posted: | February 15, 2022 |
Last Verified: | February 2022 |
Keywords provided by Organon and Co:
Hypertension |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases Losartan Amlodipine Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |