MK-0954E Study in Participants With Hypertension (MK-0954E-357)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01302691

First received: February 22, 2011

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 22, 2011
Last Updated Date	April 26, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 23, 2011)	Change in mean trough sitting diastolic blood pressure (SiDBP). [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01302691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 23, 2011)	Change in mean trough sitting systolic blood pressure (SiSBP). [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	MK-0954E Study in Participants With Hypertension (MK-0954E-357)
Official Title ^ICMJE	A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration
Brief Summary	This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium (+) hydrochlorothiazide (+) amlodipine besylate (MK-0954E [losartan/HCTZ/amlodipine]) and to find out whether losartan/HCTZ/amlodipine is better than the combination therapy of losartan potassium (+) amlodipine besylate (losartan/amlodipine) in participants with hypertension.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Drug: losartan potassium (+) hydrochlorothiazide (+) amlodipine besylate (MK-0954E) One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks. Drug: Losartan potassium One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks. Drug: Amlodipine besylate One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks. Drug: Placebo to MK-0954E One tablet, containing placebo, orally, once daily, for 8 weeks. Drug: Placebo to losartan potassium One tablet, containing placebo, orally, once daily, for 8 weeks. Drug: Placebo to amlodipine besylate One capsule, containing placebo, orally, once daily, for 8 weeks.
Study Arm (s)	Experimental: Losartan/HCTZ/amlodipine Treatment Arm Interventions: Drug: losartan potassium (+) hydrochlorothiazide (+) amlodipine besylate (MK-0954E) Drug: Placebo to losartan potassium Drug: Placebo to amlodipine besylate Active Comparator: Losartan/amlodipine Treatment Arm Interventions: Drug: Losartan potassium Drug: Amlodipine besylate Drug: Placebo to MK-0954E
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	327
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria Participant has a diagnosis of essential hypertension. Participant is being treated with single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication. Participant has a mean trough SiDBP of ≥ 90 mmHg and < 110 mmHg. Participant has a mean trough SiSBP of ≥ 140 mmHg and < 200 mmHg. Participant has no clinically significant abnormality at screening visit. Exclusion criteria Participant is currently taking > 2 antihypertensive medications. Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-Lotan or Preminent, amlodipine or dihydropyridine drug, and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines). Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence. Participant is pregnant or breastfeeding, or expecting to conceive OR the pregnancy test is positive at screening visit (Visit 1). Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Gender	Both
Ages	20 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01302691
Other Study ID Numbers ^ICMJE	MK-0954E-357
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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