We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
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.

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 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
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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