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Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

NCT ID: NCT00860262

Last Updated: 2014-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

858 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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telmisartan and amlodipine

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Group Type EXPERIMENTAL

telmisartan and amlodipine

Intervention Type DRUG

telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w

amlodipine

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Group Type ACTIVE_COMPARATOR

amlodipine

Intervention Type DRUG

amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w

telmisartan

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Group Type ACTIVE_COMPARATOR

telmisartan

Intervention Type DRUG

telmisartan 80mg for the 8w, no titration required

Interventions

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amlodipine

amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w

Intervention Type DRUG

telmisartan

telmisartan 80mg for the 8w, no titration required

Intervention Type DRUG

telmisartan and amlodipine

telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
2. Age 18 years or older
3. Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1235.20.525 Boehringer Ingelheim Investigational Site

Buena Park, California, United States

Site Status

1235.20.503 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Site Status

1235.20.507 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

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1235.20.529 Boehringer Ingelheim Investigational Site

Roseville, California, United States

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1235.20.518 Boehringer Ingelheim Investigational Site

Tustin, California, United States

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1235.20.521 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Site Status

1235.20.508 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1235.20.506 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Site Status

1235.20.519 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Site Status

1235.20.523 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Site Status

1235.20.528 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

Site Status

1235.20.516 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

1235.20.527 Boehringer Ingelheim Investigational Site

Bay City, Michigan, United States

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1235.20.510 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

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1235.20.512 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

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1235.20.509 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

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1235.20.511 Boehringer Ingelheim Investigational Site

Kettering, Ohio, United States

Site Status

1235.20.515 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

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1235.20.534 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

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1235.20.526 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

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1235.20.513 Boehringer Ingelheim Investigational Site

Tipton, Pennsylvania, United States

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1235.20.517 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

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1235.20.522 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

Site Status

1235.20.520 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1235.20.530 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

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1235.20.535 Boehringer Ingelheim Investigational Site

Draper, Utah, United States

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1235.20.533 Boehringer Ingelheim Investigational Site

Magna, Utah, United States

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1235.20.505 Boehringer Ingelheim Investigational Site

Saratoga Springs, Utah, United States

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1235.20.537 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

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1235.20.501 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

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1235.20.001 Boehringer Ingelheim Investigational Site

Burgas, , Bulgaria

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1235.20.002 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1235.20.003 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1235.20.005 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1235.20.006 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1235.20.007 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1235.20.008 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1235.20.009 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1235.20.004 Boehringer Ingelheim Investigational Site

Stara Zagora, , Bulgaria

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1235.20.052 Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, , Czechia

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1235.20.059 Boehringer Ingelheim Investigational Site

Český Krumlov, , Czechia

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1235.20.051 Boehringer Ingelheim Investigational Site

Pilsen, , Czechia

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1235.20.053 Boehringer Ingelheim Investigational Site

Prague, , Czechia

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1235.20.054 Boehringer Ingelheim Investigational Site

Příbram, , Czechia

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1235.20.055 Boehringer Ingelheim Investigational Site

Slaný, , Czechia

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1235.20.057 Boehringer Ingelheim Investigational Site

Strakonice, , Czechia

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1235.20.058 Boehringer Ingelheim Investigational Site

Tábor, , Czechia

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1235.20.101A Boehringer Ingelheim Investigational Site

Albens, , France

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1235.20.102F Boehringer Ingelheim Investigational Site

Arles, , France

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1235.20.103A Boehringer Ingelheim Investigational Site

Béziers, , France

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1235.20.103C Boehringer Ingelheim Investigational Site

Béziers, , France

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1235.20.103F Boehringer Ingelheim Investigational Site

Béziers, , France

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1235.20.106A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, , France

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1235.20.109B Boehringer Ingelheim Investigational Site

Brivé, , France

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1235.20.108E Boehringer Ingelheim Investigational Site

Carbonne, , France

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1235.20.101D Boehringer Ingelheim Investigational Site

Chambéry, , France

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1235.20.103E Boehringer Ingelheim Investigational Site

Cournonterral, , France

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1235.20.108C Boehringer Ingelheim Investigational Site

Cugnaux, , France

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1235.20.106D Boehringer Ingelheim Investigational Site

Étrelles, , France

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1235.20.108F Boehringer Ingelheim Investigational Site

Fenouillet, , France

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1235.20.102A Boehringer Ingelheim Investigational Site

Gémenos, , France

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1235.20.102C Boehringer Ingelheim Investigational Site

Gémenos, , France

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1235.20.101C Boehringer Ingelheim Investigational Site

Grésy-sur-Aix, , France

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1235.20.108A Boehringer Ingelheim Investigational Site

Labarthe-sur-Lèze, , France

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1235.20.108B Boehringer Ingelheim Investigational Site

Labarthe-sur-Lèze, , France

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1235.20.106F Boehringer Ingelheim Investigational Site

Louvigné-de-Bais, , France

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1235.20.102E Boehringer Ingelheim Investigational Site

Marseille, , France

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1235.20.106B Boehringer Ingelheim Investigational Site

Mordelles, , France

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1235.20.107A Boehringer Ingelheim Investigational Site

Orthez, , France

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1235.20.107B Boehringer Ingelheim Investigational Site

Orthez, , France

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1235.20.107E Boehringer Ingelheim Investigational Site

Orthez, , France

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1235.20.107G Boehringer Ingelheim Investigational Site

Orthez, , France

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1235.20.109A Boehringer Ingelheim Investigational Site

Rosiers-d'Égletons, , France

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1235.20.109F Boehringer Ingelheim Investigational Site

Saint-Aulaire, , France

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1235.20.104A Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

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1235.20.104D Boehringer Ingelheim Investigational Site

Saint-Etienne, , France

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1235.20.107F Boehringer Ingelheim Investigational Site

Salies-de-Béarn, , France

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1235.20.105A Boehringer Ingelheim Investigational Site

Toulon, , France

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1235.20.105D Boehringer Ingelheim Investigational Site

Toulon, , France

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1235.20.152 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1235.20.156 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1235.20.158 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1235.20.159 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1235.20.161 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1235.20.153 Boehringer Ingelheim Investigational Site

Gyöngyös, , Hungary

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1235.20.154 Boehringer Ingelheim Investigational Site

Miskolc, , Hungary

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1235.20.157 Boehringer Ingelheim Investigational Site

Miskolc, , Hungary

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1235.20.155 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, , Hungary

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1235.20.252 Boehringer Ingelheim Investigational Site

Brăila, , Romania

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1235.20.259 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1235.20.262 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1235.20.254 Boehringer Ingelheim Investigational Site

Iași, , Romania

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1235.20.261 Boehringer Ingelheim Investigational Site

Oradea, , Romania

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1235.20.256 Boehringer Ingelheim Investigational Site

Sibiu, , Romania

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1235.20.251 Boehringer Ingelheim Investigational Site

Târgu Mureş, , Romania

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1235.20.260 Boehringer Ingelheim Investigational Site

Tg. Mures, , Romania

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1235.20.253 Boehringer Ingelheim Investigational Site

Timișoara, , Romania

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1235.20.301 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1235.20.302 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1235.20.303 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1235.20.304 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1235.20.310 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1235.20.305 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1235.20.306 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1235.20.307 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1235.20.308 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1235.20.309 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1235.20.311 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1235.20.355 Boehringer Ingelheim Investigational Site

Galanta, , Slovakia

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1235.20.353 Boehringer Ingelheim Investigational Site

Košice, , Slovakia

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1235.20.352 Boehringer Ingelheim Investigational Site

Považská Bystrica, , Slovakia

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1235.20.354 Boehringer Ingelheim Investigational Site

Rimavská Sobota, , Slovakia

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1235.20.356 Boehringer Ingelheim Investigational Site

Trnava, , Slovakia

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1235.20.351 Boehringer Ingelheim Investigational Site

Vráble, , Slovakia

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1235.20.207 Boehringer Ingelheim Investigational Site

Busan, , South Korea

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1235.20.206 Boehringer Ingelheim Investigational Site

Junam, , South Korea

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1235.20.205 Boehringer Ingelheim Investigational Site

Koyang, , South Korea

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1235.20.201 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1235.20.202 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1235.20.203 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1235.20.204 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1235.20.406 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

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1235.20.408 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

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1235.20.402 Boehringer Ingelheim Investigational Site

Granada, , Spain

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1235.20.403 Boehringer Ingelheim Investigational Site

Seville, , Spain

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1235.20.409 Boehringer Ingelheim Investigational Site

Valencia, , Spain

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1235.20.451 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1235.20.458 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

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1235.20.460 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

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1235.20.453 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.20.454 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.20.455 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.20.456 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.20.457 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.20.461 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

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1235.20.452 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1235.20.459 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

Countries

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United States Bulgaria Czechia France Hungary Romania Russia Slovakia South Korea Spain Ukraine

Other Identifiers

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2008-000873-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1235.20

Identifier Type: -

Identifier Source: org_study_id

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