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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041807
First Posted: January 1, 2010
Last Update Posted: April 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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 Intervention
Hypertension Drug: amlodipine/losartan

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 669
Study Start Date: February 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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
No Contacts or Locations Provided
  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 Submitted: December 31, 2009
First Posted: January 1, 2010
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