Terminated/Withdrawn

Chronic Stable Angina

Bayer Identifier:

12484

ClinicalTrials.gov Identifier:

NCT00518921

EudraCT Number:

Not Available

EU CT Number:

Not Available

Capadenoson in Angina Pectoris

Trial purpose

This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.

Key Participants Requirements

Sex

Both

Age

35 - 75 Years

Inclusion Criteria
- The primary diagnosis is chronic stable angina of mild-moderate intensity as defined by the Canadian Cardiovascular Society Functional Class II-III, in the presence of definitive coronary artery disease.
- Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized)
- Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks
Exclusion Criteria
- Inability to withdraw current anti-anginal therapy
- Inability to withdraw any concomitant therapy that would interfere with interpretation of study results

Trial summary

Enrollment Goal

Trial Dates

March 2008 - November 2008

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Capadenoson (BAY68-4986)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Terminated	SP Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego	Katowice, 40-635, Poland
Terminated	SP Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego	Katowice, 40-635, Poland
Terminated	IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ	Wroclaw, 50-981, Poland
Terminated	SP Szpital Kliniczny nr 2 PAM	Szczecin, 70-111, Poland
Terminated	Szpital Praski p.w.Przemienienia Panskiego , SPZOZ	Warszawa, 03-401, Poland
Terminated	Centrum Medycyny Ratunkowej -Dolnoslaski Szpital Specjal.	Wroclaw, 50-420, Poland
Not yet recruiting	AULSS 12 Veneziana - Veneto	Mestre, 30174, Italy
Not yet recruiting	ASS 1 Triestina - Fiuli	Trieste, 34100, Italy
Not yet recruiting	Poliklinika LIPA centrum	Praha 13, 158 00, Czech Republic
Not yet recruiting	Fakultni nemocnice s poliklinikou Ostrava	Ostrava, 708 52, Czech Republic
Not yet recruiting	Fakultni nemocnice u sv. Anny	Brno, 656 91, Czech Republic
Not yet recruiting	Kromerizska nemocnice a.s.	Kromeriz, 767 55, Czech Republic
Not yet recruiting	Rebecca Sieff Hospital Safed	Safed, 13100, Israel
Not yet recruiting	Bacs-Kiskun Country Hospital	Kecskemet, 6000, Hungary
Terminated	SP Szpital Kliniczny AM w Bialymstoku	Bialystok, 15-276, Poland
Terminated	Wojewodzki Szpital Specjalistyczny im. Bieganskiego	Lodz, 91-347, Poland
Terminated	Uniwersyteckie Centrum Kliniczne	Gdansk, 80-952, Poland
Terminated	Szpital Uniwersytecki CMUJ	Krakow, 30-501, Poland
Terminated	Szpital Morski im. PCK	Gdynia, 81-519, Poland
Terminated	Specjalistyczny Szpital Sw. Jana	Starogard Gdanski, 83-200, Poland
Terminated	Wojewodzki Szpital Specjalistyczny	Legnica, 59-220, Poland
Not yet recruiting	Istituto di Cura Città di Pavia	Pavia, 27100, Italy
Not yet recruiting	IRCCS Policlinico San Matteo	Pavia, 27100, Italy
Not yet recruiting	A.O.U. San Martino	Genova, 16132, Italy
Not yet recruiting	ASL Prov Pavia - Lombardia	Pavia, 27100, Italy
Not yet recruiting	Ustredni vojenska nemocnice Praha	Praha 6, 169 02, Czech Republic
Not yet recruiting	Fakultni nemocnice Plzen	Plzen, 30599, Czech Republic
Not yet recruiting	Fakultni Nemocnice Olomouc	Olomouc, 775 20, Czech Republic
Not yet recruiting	Fakultni nemocnice u sv. Anny	Brno, 656 91, Czech Republic
Not yet recruiting	Borsod County Hospital	Miskolc, 3526, Hungary
Not yet recruiting	University of Pecs, Medical & Health Science Center	Pecs, 7624, Hungary
Not yet recruiting	Faculty Hospital with Polyclinic	Nove Zamky, 940 34, Slovakia
Not yet recruiting	Kardiocentrum Nitra s.r.o.	Nitra, 949 01, Slovakia
Not yet recruiting	Cardioconsult s.r.o.	Bratislava, 811 04, Slovakia
Not yet recruiting	Nemocnice TGM Hodonin	Hodonin, 695 26, Czech Republic
Not yet recruiting	Hillel Yaffe Medical Center	Hadera, 38100, Israel
Not yet recruiting	Kaplan Medical Center	Rehovot, 76100, Israel
Not yet recruiting	Zala Megyei Korhaz	Zalaegerszeg, 8900, Hungary
Not yet recruiting	Allami Szivkorhaz	Balatonfured, 8230, Hungary
Not yet recruiting	Fakultna nemocnica Stare Mesto	Bratislava, 813 69, Slovakia

Primary Outcome

Total exercise time
Time Frame:
28 days for ETT and 42 days for safety
Safety Issue:
no

Secondary Outcome

Time to angina onset
Time Frame:
28 days
Safety Issue:
no

Trial design

Phase IIa Efficacy and Safety Trial of capadenoson in Patients with Chronic Stable Angina

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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