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Cozaar XQ Re-examination Study (MK-0954-349 AM3)

This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01041807
First received: December 31, 2009
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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: 900
Study Start Date: February 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041807

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Yong Soo (STEVE) Kim     82 2 331 2014        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01041807     History of Changes
Other Study ID Numbers: 0954-349, 2009_004
Study First Received: December 31, 2009
Last Updated: March 22, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck:
Hypertension

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

ClinicalTrials.gov processed this record on May 16, 2013