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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 : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Hypertension Drug: amlodipine/losartan

Study Design
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Study Type : Observational
Actual Enrollment : 669 participants
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

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
All participants
Participants with hypertension treated with amlodipine/losartan(Cozaar XQ)
 Drug: amlodipine/losartan
amlodipine/losartan (COZAAR XQ) prescribed according to the current local label
Other Name: COZAAR XQ


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with any adverse experience [ Time Frame: Up to 14 days after last treatment ]
  2. 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 :
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01041807     History of Changes
Other Study ID Numbers: 0954-349
2009_004 ( Other Identifier: Merck Registration Number )
First Posted: January 1, 2010    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Losartan
Antihypertensive Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists