A Study to Investigate the Influence of MK0859 on Blood Pressure (MK-0859-012)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00565006

Recruitment Status : Completed

First Posted : November 29, 2007

Last Update Posted : February 27, 2015

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Tracking Information

First Submitted Date ^ICMJE

November 27, 2007

First Posted Date ^ICMJE

November 29, 2007

Last Update Posted Date

February 27, 2015

Study Start Date ^ICMJE

July 2006

Actual Primary Completion Date

September 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00565006 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Investigate the Influence of MK0859 on Blood Pressure (MK-0859-012)(COMPLETED)

Official Title ^ICMJE

Not Provided

Brief Summary

This study will investigate the influence of MK0859 on ambulatory blood pressure, and how safe and tolerable MK0859 is on the subjects This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Ambulatory Blood Pressure

Intervention ^ICMJE

Drug: MK0859

Study Arms

Not Provided

Publications *

Krishna R, Anderson MS, Bergman AJ, Jin B, Fallon M, Cote J, Rosko K, Chavez-Eng C, Lutz R, Bloomfield DM, Gutierrez M, Doherty J, Bieberdorf F, Chodakewitz J, Gottesdiener KM, Wagner JA. Effect of the cholesteryl ester transfer protein inhibitor, anacetrapib, on lipoproteins in patients with dyslipidaemia and on 24-h ambulatory blood pressure in healthy individuals: two double-blind, randomised placebo-controlled phase I studies. Lancet. 2007 Dec 8;370(9603):1907-14.

* 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

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date

September 2006

Actual Primary Completion Date

September 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

You are between the ages of 45-75
You are a man or non-pregnant woman
You agree to not eat or drink fruit or fruit juices (orange, apple or grapefruit) for 2 weeks before starting study medication

Exclusion Criteria:

You have smoked or used other nicotine-containing products (chewing tobacco) within the last 6 months
You have used St. John's Wort or any products that include it within the last 2 weeks
You have used herbal, organic, dietary or nutritional remedies within the last 2 weeks
You have a history of drug allergies (anaphylaxis, angioedema)
You have taken an investigational drug in another clinical trial within the last 4 weeks
You have a history of cardiovascular disease including hypertension (high blood pressure)
You have a history of renal disease
You have a history of gall bladder disease or have had abnormal liver function tests
You have a history of drug or alcohol abuse
You drink more than 6 cups of caffeinated beverages a day (coffee, tea or cola)

Sex/Gender

Sexes Eligible for Study:

All

Ages

45 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00565006

Other Study ID Numbers ^ICMJE

0859-012
2007_656

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck Sharp & Dohme Corp.

PRS Account

Merck Sharp & Dohme Corp.

Verification Date

February 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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