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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01041807
First received: December 31, 2009
Last updated: September 26, 2014
Last verified: September 2014
  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 ] [ 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: December 2014
Estimated Primary Completion Date: December 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
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

Locations
Korea, Republic of
MSD Korea LTD
Seoul, Korea, Republic of
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01041807     History of Changes
Other Study ID Numbers: 0954-349, 2009_004
Study First Received: December 31, 2009
Last Updated: September 26, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hypertension

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

ClinicalTrials.gov processed this record on October 19, 2014