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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT01041807

First received: December 31, 2009

Last updated: April 9, 2015

Last verified: April 2015

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:

Drug Information available for: Amlodipine Amlodipine besylate Losartan Losartan potassium

U.S. FDA Resources

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 ]


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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

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
Study First Received:	December 31, 2009
Last Updated:	April 9, 2015
Health Authority:	Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016

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