NCT00518921

Brief Summary

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.

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
6 countries

36 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 13, 2011

Status Verified

January 1, 2011

First QC Date

August 20, 2007

Last Update Submit

January 12, 2011

Conditions

Chronic Stable Angina

Keywords

adenosin agonistchronic stable angina

Outcome Measures

Primary Outcomes (1)

  • Total exercise time

    28 days for ETT and 42 days for safety

Secondary Outcomes (1)

  • Time to angina onset

    28 days

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: Capadenoson (BAY 68-4986)

Arm 2

EXPERIMENTAL
Drug: Capadenoson (BAY 68-4986)

Arm 3

EXPERIMENTAL
Drug: Capadenoson (BAY 68-4986)

Arm 4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Capadenoson (BAY 68-4986)DRUG

1mg Capadenoson, double dummy

Arm 1
PlaceboDRUG

Placebo, double dummy

Arm 4

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to withdraw current anti-anginal therapy
  • Inability to withdraw any concomitant therapy that would interfere with interpretation of study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Unknown Facility

Brno, 656 91, Czechia

Location

Unknown Facility

Hodonín, 695 26, Czechia

Location

Unknown Facility

Kroměříž, 767 55, Czechia

Location

Unknown Facility

Olomouc, 775 20, Czechia

Location

Unknown Facility

Ostrava, 708 52, Czechia

Location

Unknown Facility

Pilsen, 30599, Czechia

Location

Unknown Facility

Prague, 158 00, Czechia

Location

Unknown Facility

Prague, 169 02, Czechia

Location

Unknown Facility

Balatonfüred, 8230, Hungary

Location

Unknown Facility

Kecskemét, 6000, Hungary

Location

Unknown Facility

Miskolc, 3526, Hungary

Location

Unknown Facility

Pécs, 7624, Hungary

Location

Unknown Facility

Zalaegerszeg, 8900, Hungary

Location

Unknown Facility

Hadera, Israel, 38100, Israel

Location

Unknown Facility

Rehovot, Israel, 76100, Israel

Location

Unknown Facility

Safed, Israel, 13100, Israel

Location

Unknown Facility

Mestre, Venezia, 30174, Italy

Location

Unknown Facility

Genova, 16132, Italy

Location

Unknown Facility

Pavia, 27100, Italy

Location

Unknown Facility

Trieste, 34100, Italy

Location

Unknown Facility

Bialystok, 15-276, Poland

Location

Unknown Facility

Gdansk, 80-952, Poland

Location

Unknown Facility

Gdynia, 81-519, Poland

Location

Unknown Facility

Katowice, 40-635, Poland

Location

Unknown Facility

Krakow, 30-501, Poland

Location

Unknown Facility

Legnica, 59-220, Poland

Location

Unknown Facility

Lodz, 91-347, Poland

Location

Unknown Facility

Starogard Gdański, 83-200, Poland

Location

Unknown Facility

Szczecin, 70-111, Poland

Location

Unknown Facility

Warsaw, 03-401, Poland

Location

Unknown Facility

Wroclaw, 50-420, Poland

Location

Unknown Facility

Wroclaw, 50-981, Poland

Location

Unknown Facility

Bratislava, 811 04, Slovakia

Location

Unknown Facility

Bratislava, 813 69, Slovakia

Location

Unknown Facility

Nitra, 949 01, Slovakia

Location

Unknown Facility

Nové Zámky, 940 34, Slovakia

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

capadenoson

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 21, 2007

Study Start

March 1, 2008

Study Completion

November 1, 2008

Last Updated

January 13, 2011

Record last verified: 2011-01

Locations

IT(4)CZ(8)HU(5)PL(12)IL(3)SL(4)