Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010 AM1)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01337674

First received: April 15, 2011

Last updated: December 9, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 15, 2011
Last Updated Date	December 9, 2011
Start Date ^ICMJE	April 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 15, 2011)	Number of participants who experience clinical or laboratory adverse events [ Time Frame: Day 1 to 14 days following the last dose of study drug (approximately 60 days) ] [ Designated as safety issue: Yes ] Change from baseline in systolic blood pressure [ Time Frame: Baseline and Day 1 ] [ Designated as safety issue: No ] Change from baseline in systolic blood pressure [ Time Frame: Baseline and Day 7 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01337674 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 15, 2011)	Steady-state area under the concentration versus time curve [AUC(0-24hr)] for MK-4618 [ Time Frame: Day 7 ] [ 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	Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010 AM1)
Official Title ^ICMJE	A Study to Evaluate the Co-Administration of MK-4618 With Antihypertensive Agents
Brief Summary	This study will evaluate the safety and tolerability of MK-4618 when coadministered with antihypertensive agents and will evaluate changes in blood pressure following co-administration of MK-4618 with a beta blocker and a vasodilator.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Drug: MK-4618 Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 Drug: Placebo for MK-4618 Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 Drug: metoprolol Previously prescribed daily dose of open-label metoprolol for the duration of the study Other Name: Toprol-XL Drug: amlodipine Previously prescribed daily dose of open-label amlodipine for the duration of the study Other Name: Norvasc
Study Arm (s)	Experimental: Panel A: MK-4618 then Placebo MK-4618 and metoprolol in Period 1, followed by placebo and metoprolol in Period 2 Interventions: Drug: MK-4618 Drug: Placebo for MK-4618 Drug: metoprolol Experimental: Panel A: Placebo then MK-4618 Placebo and metoprolol in Period 1, followed by MK-4618 and metoprolol in Period 2 Interventions: Drug: MK-4618 Drug: Placebo for MK-4618 Drug: metoprolol Experimental: Panel B: MK-4618 then Placebo MK-4618 and amlodipine in Period 1, followed by placebo and amlodipine in Period 2 Interventions: Drug: MK-4618 Drug: Placebo for MK-4618 Drug: amlodipine Experimental: Panel B: Placebo then MK-4618 Placebo and amlodipine in Period 1, followed by MK-4618 and amlodipine in Period 2 Interventions: Drug: MK-4618 Drug: Placebo for MK-4618 Drug: amlodipine
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	26
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female not of childbearing potential Not a nursing mother Must be on stable dose of a beta blocker (Panel A only) or amlodipine (Panel B only) for the treatment of hypertension for at least 6 weeks prior to enrollment. Must take the designated daily dose of metoprolol or amlodipine for the duration of the study In good health other than hypertension Nonsmoker Participant has a resting systolic blood pressure of <160 mmHg and a diastolic blood pressure <100 mmHg prior to randomization Exclusion Criteria: Any illness that might confound the results of the study or pose a risk by participation History of orthostatic hypotension (decrease in blood pressure upon standing accompanied by symptoms of lightheadedness or dizziness) History of cancer, excepting certain skin or cervical cancers or cancers that were treated successfully 10 or more years prior to screening Condition for which there is a warning, contraindication, or precaution against the use of extended release metoprolol (Panel A) or amlodipine (Panel B) Consumes excessive amounts of alcohol or caffeine daily Has multiple and/or severe allergies (including latex allergy) or has had an anaphylactic reaction or significant intolerance to drugs or food Uses illicit drugs or has a history of drug abuse
Gender	Both
Ages	18 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	NCT01337674
Other Study ID Numbers ^ICMJE	MK-4618-010
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	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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