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103 documents found matching cs:ernst*.
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Showing 1-10 of 103 documents
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1.
Q&A re label change
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Document Date:
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20020411
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Document Type:
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memo
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-ABG0001226-1243
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Exhibit Number:
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168
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Search Terms in Context:
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VIOXX® Label Change
Questions & Answers
For internal use only in response to media inquiries
FINAL: 4/11/02
LABEL CHANGES
Q1. Tell me about this label change for Vioxx approved by the FDA.
A1. The label changes approved by the FDA include the addition of the findings from
VIGOR, including Gl and cardiovascular results, along with cardiovascular results from a placebo-controlled database; and the addition of an expanded indication for a new use of Vioxx 25 mg in adult rheumatoid arthritis.
Q2. Why did it take so long to receive this approval? Why didn't you include the cardiovascular findings from VIGOR in your label sooner?
A2. Merck first announced the preliminary results of the VIGOR study in March 2000. Since that time, the results have been presented at major medical meetings, published in the
........New-England Journal of Medicine, discussed at a public meeting of the FDA advisory
committee, and debated in both the medical and lay press. We believe the results have been broa
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http://dida.library.ucsf.edu/tid/oxx05n10
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2.
Vigor
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Document Date:
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20000309
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Author:
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Scolnick, Edward
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Recipient:
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Shapiro, Deborah|Reicin, Alise|Nies, Alan
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Document Type:
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e-mail
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-ABH0016219-4346
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Exhibit Number:
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186
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Search Terms in Context:
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To:
Shapiro, Deborah R.; Reicin, Alise S.; Nies, Alan S.
From:
Scolníck, Edward hÁ.
Ce
Scolnlck, Edward M.
Bec:
Date:
2000-03-09 23:18:40
Subject:
vigor
To all: I just received and went through the data. Thank you for sending it to me. There is no doubt about the pub data, very very strong, as expected, general safety is better than couid hope for in this patient population, incidences of hypertension, renal anything ,edema, liver, all great-very safe.very very safe. The CV events are clearly there. Since no obvious correlate right now ie not steroids , maybe smoking and prior a bit this is real. It is important to find out about the cases that oates told us about. When we present in May we should present those also if he will let us so it is clear to the world that this is class effect, all the ideas you talked about are important: pltpid antibodies-but 1 doubt it will correlate.Many vein tbosis in what is probably a somewhat restricted patient group. I think we should run an asa low dose endosc
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3.
DWQ -- Johnson County Medical Examiner [Autopsy Ernst]
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Document Date:
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20041210
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Document Type:
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report
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-ERNST00236-0251
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Exhibit Number:
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1365
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Search Terms in Context:
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NAARK.I.TH-.ÌKOUI--
J'lWir_-:íl ,'<•:. Du
!/îiO'.îNop.iMwi.si i-w'v mïîii ¡oc 11;--: ¡ :¦¦¦>.<' v ::.C40
i; : 713 43 íó ! '.".'i '•">
STYLS OF
case : Carol A. Ernst, Individually and as Personal Representative of the Estate and Heirs of Robert Charles Ernst, deceased R. Charles Ernst, Angela-F. Ernst vs.-
Merck & Co., Inc., Harvey Resnkk, M.D., and R/D Clinical Research, Inc.
CASE NO. : 19961*BH02
PERTAIN TO : Robert C. Ernst
FROM : Johnson County Medical Examiner Autopsy
DELIVDi TO : Eugene R. Kf;tIorr
LANIER LAW 1'TRiM 6810 I'M i960 West Houston, TX 77069
In the 23rd Judicial District Court in and !W Brazoria County, Texas
The taxable cost of $ 471.25 was charged to Attorney for Plaintiff, '1 ¿SLIDES Order No. 01-S79X6-H08
pgNbr=1
cause No. immïmz
Carol A. Ernst, Twîjvifftiftlh' itiiù" as Personal
Representative or the VMlti?. anû Heirs of
Robert Charle* Ernst, decesseci
R. Charles Ernst, Angela F. Ernst
vs.
Merck & Co,, Inc., Harvey Rcini
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http://dida.library.ucsf.edu/tid/oxx07o10
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4.
Profit Plan 2002 Merck A & A Franchise
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Document Date:
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20020101
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Document Type:
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report
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-AAO0000119-0145
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Exhibit Number:
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2002
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Search Terms in Context:
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Profit Pían 2002 - Merck A&A Franchise
Confidential - Subject To Protective Order
MRK-MO0000119
pgNbr=1
Executive Summary
The year 2002 will define the future of the Merck coxib f ranchtse In several important ways. First, a new competitiva entrant, valdecoxfc, wiH enter the market. In order to be successful, the- A&A franchise will need to pre-position valdecoxib as offen'ng nothing new while also addressing continued competitive pressures from Celebrex. VIOXX will compete atone against two Pharmacia ooxibsurrtil the launch of etoricoxib. Seconó, etoricoxib wir! launch in July into a market where success or failure are determinad In tha first 12 months of post-launch performance. For these reasons, franchisa spending emphasis win shift from VIOXX in the first half of the year to etorlcoxfo in the second half.
Th» most Ikaly revenue forecast1 forth« franchise is $2,2 biBton, comprised of $1.9 btlfion for VIOXX and $305 MM (which includes $60 MM stocking) for etoricoxib. This compares to the franchisa re
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http://dida.library.ucsf.edu/tid/oxx08w10
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5.
Affidavit -- Cleburne Internal Medicine/Dr. Brent Wallace
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Document Date:
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20030402
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Document Type:
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report
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-ERNST00252-0265
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Exhibit Number:
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1373
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Search Terms in Context:
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AFFIDAVI!
MEDICAI. RECORDS PERTAINING TO:
ROBERT CHARI.ES ERNST (SSN: 494-42-4756; DOB: 02/11/42)
Before me, the undersigned authority, personally appeared \J0Ni j\' h f\ ¦ ) v-> ^ t frJ jjSj.C^_________;
who by me being duly sworn, deposed as follows:
I, the undersigned, am over 18 years of age, of sound mind, capable of making this affidavit, and personally acquainted with the facts herein stated:
I AM THE CUSTODIAN OF RECORDS FOR:
CLEBURNE INTERNAL MEDICINE ASSOCIATES / WALLACE, BRENT H., MD
Attached hereto arc ; --} pages of records and O photographs. These said records are kept in the regular course of busiaess, at the office of the above, and it was in the regular course of business, at the office of the above, for an employee, representative, or a doctor with personal knowledge of the act, event or condition, opinion, or diagnosis recorded to make the memorandum or record or to transmit information thereof to be included in such memorandum or record. The memorandum or re
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http://dida.library.ucsf.edu/tid/oxx07p10
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6.
Westrick letter to Abrams -- FDA
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Document Date:
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20000915
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Document Type:
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letter
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-AAF0007286-7293
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Exhibit Number:
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1652
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Search Terms in Context:
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#>+ MERCK
^¦s®^ u.i«n*fi L4a*iIik n!i.;^;ni
Ellen WestriCi, executive Director Office of Medical/Legal
Human Heallíi Division „ , ,_ ,..„,.„.,,_„
P.O.BOX4.WP37C-116 Prione #: (215)652-3476
West Point. PA 19486 Fax #: (215)652-2178
RUSH - PLEASE HAND DELIVER !!
To: Food and Drug Administration
Division of Drug Marketing, Advertising and Communications
Fax H: (301) 594-6771 (Guyann)
Attention: Mr. Thomas Abrams, RPh, MBA ________
MACMIS # or Product: VIOXX
Oate: 9/15/00 Time: 1:27pm Total Pages: 8
(including cover)
If you do not receive all page», please call Oiane Tansay @ (215) 652-4671. Thank you. im DOCiM(x7i tccofAtrnho t«j tuicorx« iiuusuiiion ctxi** •tfOUwncM "ou muck 4 Co. we. «hcm ej eotMWnu uo«
UGAUT ^ÍVHIOCÍO. Iht wrfowjMwi » IwiMil
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7.
Email re Vioxx label
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Document Date:
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20011016
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Document Type:
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e-mail
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-ABW0004799
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Exhibit Number:
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346
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Search Terms in Context:
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Anstice, David W.
From: Scolnick, Edward M.
Sent; Tuesday. October 16, 2001 12:06 AM
To: Anstice, David W.
Subject: RE: vioxx label
it is ugly cubed, thye are bastards
—Original Message— From: Anstice, David w.
Sent: Monday, October 15, 2001 6:32 FM
To: Scolnick Edward M.
Subject: RE: vioxx labe!
Ed, Thanks.l Just received a copy 5 minutes ago and will digest tonight. Wb knew it would be UGLY and it is. We'll right back and see where we get. | agree that we should ask for an advisory committee if necessary David
-----Original Message------
From: Scolnick, Edward M.
Sent: Monday, October IS, 2001 6:02 PM
To: Anstice, David VA
Subject: vioxx label
David Be assured v/e will not accept this label if we need to
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8.
Recommended plan -- targeted A&A thought leaders
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Document Date:
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00000000
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Document Type:
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table
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-NJ0197019-7028
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Exhibit Number:
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827
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Search Terms in Context:
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Recommended Plan - Targeted A&A Thought Leaders
James Tries, M.P.*
Objective: To balance relationship in non-product oriented manner (ie. epidemiology)
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9.
Letter to Westrick re Prinivil
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Document Date:
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19970314
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Document Type:
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letter
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-ERNST00001-0003
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Exhibit Number:
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901
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Search Terms in Context:
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DEPARTMENT OF HEALTH &. HUMAN SERVICES Public Health Service
___________________________________________________________________________________
Food and Drug Administration Rockville MD 20857
MAR I 4 1997 TRANSMITTED VIA FACSIMILE
Ellen R. Westrick Senior Director Office of Medical/Legal Merck & Co., Inc. Sumneytown Pike West Point, PA 19486
RE: NDA# 19-558
Prinivil (lisinopril) Tablets MACMISrD#5235
Dear Ms Westrick:
The Division of Drug Marketing, Advertising and Communications (DDMAC), as part of its routine surveillance program, has reviewed ajournai advertisement and brochure promoting Prinivä (lisinopril) tablets that was ciisseminated by or on behalf of Merck & Co., Inc., (Merck). These materials describe Cal Ripken, Jr., as being "The Hardest Working Man in Baseball, " and contain concurrent references to Mr. Ripken and Prinivil.
DDMAC has reviewed these promotional pieces and concluded that they are in violation of the Federal Food, Drag
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10.
Clinical study report re MK-0966
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Document Date:
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20000510
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Document Type:
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report
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Case Number:
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Ernst v. Merck & Co. Inc., District Court of Brazoria County, Texas, Cause No. 19961*BHO2
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Bates Number:
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MRK-AAX0001725-1833
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Exhibit Number:
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1628
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Search Terms in Context:
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MERCK RESEARCH CLINICAL STUDY REPORT
LABORATORIES I. SYNOPSIS
MK-0966 Rofecoxib Tablets
PROTOCOL TITLE/NO.: A Double-Blind, Randomized, Stratified, Parallel-Group #088/089 Study to Assess the Incidence of PUBs During Chronic Treatment With MK-0966 or Naproxen in Patients With Rheumatoid Arthritis___________________
INVESTIGATOR(S)/STUDY CENTER(S): Multinational (308)______________________________
PUBLICATION(S):
PRIMARY THERAPY PERIOD:
CLINICAL PHASE: Illb
DURATION OF TREATMENT: The first patient received study therapy on 14-Jan-1999. The VIGOR Steering Committee set an early termination date of l7-Feb-2000 (date on which end of study visits
could begin to be conducted). The last dose of study drug was taken on 17-Mar-2000_______________
OBJECTIVE(S): (1) To determine the relative risk of confirmed PUBs in patients taking MK-0966 50 mg daily, compared to patients in the group taking naproxen 1000 mg/day. (2)
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