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

Last updated: May 16, 2014
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

3

Condition

Stress

Circulation Disorders

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT00860262
1235.20
2008-000873-40
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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)

Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg

Study Design

Total Participants: 858
Study Start date:
March 01, 2009
Estimated Completion Date:

Connect with a study center

  • 1235.20.001 Boehringer Ingelheim Investigational Site

    Bourgas,
    Bulgaria

    Site Not Available

  • 1235.20.002 Boehringer Ingelheim Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • 1235.20.003 Boehringer Ingelheim Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • 1235.20.005 Boehringer Ingelheim Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • 1235.20.006 Boehringer Ingelheim Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • 1235.20.007 Boehringer Ingelheim Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • 1235.20.008 Boehringer Ingelheim Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • 1235.20.009 Boehringer Ingelheim Investigational Site

    Sofia,
    Bulgaria

    Site Not Available

  • 1235.20.004 Boehringer Ingelheim Investigational Site

    Stara Zagora,
    Bulgaria

    Site Not Available

  • 1235.20.052 Boehringer Ingelheim Investigational Site

    Benatky nad Jizerou,
    Czech Republic

    Site Not Available

  • 1235.20.059 Boehringer Ingelheim Investigational Site

    Cesky Krumlov,
    Czech Republic

    Site Not Available

  • 1235.20.051 Boehringer Ingelheim Investigational Site

    Plzen,
    Czech Republic

    Site Not Available

  • 1235.20.053 Boehringer Ingelheim Investigational Site

    Praha 5,
    Czech Republic

    Site Not Available

  • 1235.20.054 Boehringer Ingelheim Investigational Site

    Pribram,
    Czech Republic

    Site Not Available

  • 1235.20.055 Boehringer Ingelheim Investigational Site

    Slany,
    Czech Republic

    Site Not Available

  • 1235.20.057 Boehringer Ingelheim Investigational Site

    Strakonice,
    Czech Republic

    Site Not Available

  • 1235.20.058 Boehringer Ingelheim Investigational Site

    Tabor,
    Czech Republic

    Site Not Available

  • 1235.20.101A Boehringer Ingelheim Investigational Site

    Albens,
    France

    Site Not Available

  • 1235.20.102F Boehringer Ingelheim Investigational Site

    Arles,
    France

    Site Not Available

  • 1235.20.103A Boehringer Ingelheim Investigational Site

    Beziers,
    France

    Site Not Available

  • 1235.20.103C Boehringer Ingelheim Investigational Site

    Beziers,
    France

    Site Not Available

  • 1235.20.103F Boehringer Ingelheim Investigational Site

    Beziers,
    France

    Site Not Available

  • 1235.20.106A Boehringer Ingelheim Investigational Site

    Bourg des cptes,
    France

    Site Not Available

  • 1235.20.109B Boehringer Ingelheim Investigational Site

    Brive,
    France

    Site Not Available

  • 1235.20.108E Boehringer Ingelheim Investigational Site

    Carbonne,
    France

    Site Not Available

  • 1235.20.101D Boehringer Ingelheim Investigational Site

    Chambery,
    France

    Site Not Available

  • 1235.20.103E Boehringer Ingelheim Investigational Site

    Cournonterral,
    France

    Site Not Available

  • 1235.20.108C Boehringer Ingelheim Investigational Site

    Cugnaux,
    France

    Site Not Available

  • 1235.20.106D Boehringer Ingelheim Investigational Site

    Etrelles,
    France

    Site Not Available

  • 1235.20.108F Boehringer Ingelheim Investigational Site

    Fenouillet,
    France

    Site Not Available

  • 1235.20.102A Boehringer Ingelheim Investigational Site

    Gemenos,
    France

    Site Not Available

  • 1235.20.102C Boehringer Ingelheim Investigational Site

    Gemenos,
    France

    Site Not Available

  • 1235.20.101C Boehringer Ingelheim Investigational Site

    Gresy Sur Aix,
    France

    Site Not Available

  • 1235.20.108A Boehringer Ingelheim Investigational Site

    Labarthe Sur Leze,
    France

    Site Not Available

  • 1235.20.108B Boehringer Ingelheim Investigational Site

    Labarthe sur Leze,
    France

    Site Not Available

  • 1235.20.106F Boehringer Ingelheim Investigational Site

    Louvigne De bais,
    France

    Site Not Available

  • 1235.20.102E Boehringer Ingelheim Investigational Site

    Marseille,
    France

    Site Not Available

  • 1235.20.106B Boehringer Ingelheim Investigational Site

    Mordelles,
    France

    Site Not Available

  • 1235.20.107A Boehringer Ingelheim Investigational Site

    Ortez,
    France

    Site Not Available

  • 1235.20.107B Boehringer Ingelheim Investigational Site

    Orthez,
    France

    Site Not Available

  • 1235.20.107E Boehringer Ingelheim Investigational Site

    Orthez,
    France

    Site Not Available

  • 1235.20.107G Boehringer Ingelheim Investigational Site

    Orthez,
    France

    Site Not Available

  • 1235.20.109A Boehringer Ingelheim Investigational Site

    Rosiers d'Egletons,
    France

    Site Not Available

  • 1235.20.109F Boehringer Ingelheim Investigational Site

    Saint Aulaire,
    France

    Site Not Available

  • 1235.20.104A Boehringer Ingelheim Investigational Site

    Saint Etienne,
    France

    Site Not Available

  • 1235.20.104D Boehringer Ingelheim Investigational Site

    Saint Etienne,
    France

    Site Not Available

  • 1235.20.107F Boehringer Ingelheim Investigational Site

    Salies de Bearn,
    France

    Site Not Available

  • 1235.20.105A Boehringer Ingelheim Investigational Site

    Toulon,
    France

    Site Not Available

  • 1235.20.105D Boehringer Ingelheim Investigational Site

    Toulon,
    France

    Site Not Available

  • 1235.20.152 Boehringer Ingelheim Investigational Site

    Budapest,
    Hungary

    Site Not Available

  • 1235.20.156 Boehringer Ingelheim Investigational Site

    Budapest,
    Hungary

    Site Not Available

  • 1235.20.158 Boehringer Ingelheim Investigational Site

    Budapest,
    Hungary

    Site Not Available

  • 1235.20.159 Boehringer Ingelheim Investigational Site

    Budapest,
    Hungary

    Site Not Available

  • 1235.20.161 Boehringer Ingelheim Investigational Site

    Budapest,
    Hungary

    Site Not Available

  • 1235.20.153 Boehringer Ingelheim Investigational Site

    Gyongyos,
    Hungary

    Site Not Available

  • 1235.20.154 Boehringer Ingelheim Investigational Site

    Miskolc,
    Hungary

    Site Not Available

  • 1235.20.157 Boehringer Ingelheim Investigational Site

    Miskolc,
    Hungary

    Site Not Available

  • 1235.20.155 Boehringer Ingelheim Investigational Site

    Mosonmagyarovar,
    Hungary

    Site Not Available

  • 1235.20.207 Boehringer Ingelheim Investigational Site

    Busan,
    Korea, Republic of

    Site Not Available

  • 1235.20.206 Boehringer Ingelheim Investigational Site

    Chunan,
    Korea, Republic of

    Site Not Available

  • 1235.20.205 Boehringer Ingelheim Investigational Site

    Koyang,
    Korea, Republic of

    Site Not Available

  • 1235.20.201 Boehringer Ingelheim Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1235.20.202 Boehringer Ingelheim Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1235.20.203 Boehringer Ingelheim Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1235.20.204 Boehringer Ingelheim Investigational Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • 1235.20.252 Boehringer Ingelheim Investigational Site

    Braila,
    Romania

    Site Not Available

  • 1235.20.259 Boehringer Ingelheim Investigational Site

    Bucharest,
    Romania

    Site Not Available

  • 1235.20.262 Boehringer Ingelheim Investigational Site

    Bucharest,
    Romania

    Site Not Available

  • 1235.20.254 Boehringer Ingelheim Investigational Site

    Iasi,
    Romania

    Site Not Available

  • 1235.20.261 Boehringer Ingelheim Investigational Site

    Oradea,
    Romania

    Site Not Available

  • 1235.20.256 Boehringer Ingelheim Investigational Site

    Sibiu,
    Romania

    Site Not Available

  • 1235.20.251 Boehringer Ingelheim Investigational Site

    Targu-Mures,
    Romania

    Site Not Available

  • 1235.20.260 Boehringer Ingelheim Investigational Site

    Tg. Mures,
    Romania

    Site Not Available

  • 1235.20.253 Boehringer Ingelheim Investigational Site

    Timisoara,
    Romania

    Site Not Available

  • 1235.20.301 Boehringer Ingelheim Investigational Site

    Moscow,
    Russian Federation

    Site Not Available

  • 1235.20.302 Boehringer Ingelheim Investigational Site

    Moscow,
    Russian Federation

    Site Not Available

  • 1235.20.303 Boehringer Ingelheim Investigational Site

    Moscow,
    Russian Federation

    Site Not Available

  • 1235.20.304 Boehringer Ingelheim Investigational Site

    Moscow,
    Russian Federation

    Site Not Available

  • 1235.20.310 Boehringer Ingelheim Investigational Site

    Moscow,
    Russian Federation

    Site Not Available

  • 1235.20.305 Boehringer Ingelheim Investigational Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 1235.20.306 Boehringer Ingelheim Investigational Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 1235.20.307 Boehringer Ingelheim Investigational Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 1235.20.308 Boehringer Ingelheim Investigational Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 1235.20.309 Boehringer Ingelheim Investigational Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 1235.20.311 Boehringer Ingelheim Investigational Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 1235.20.355 Boehringer Ingelheim Investigational Site

    Galanta,
    Slovakia

    Site Not Available

  • 1235.20.353 Boehringer Ingelheim Investigational Site

    Kosice,
    Slovakia

    Site Not Available

  • 1235.20.352 Boehringer Ingelheim Investigational Site

    Povazska Bystrica,
    Slovakia

    Site Not Available

  • 1235.20.354 Boehringer Ingelheim Investigational Site

    Rimavska Sobota,
    Slovakia

    Site Not Available

  • 1235.20.356 Boehringer Ingelheim Investigational Site

    Trnava,
    Slovakia

    Site Not Available

  • 1235.20.351 Boehringer Ingelheim Investigational Site

    Vrable,
    Slovakia

    Site Not Available

  • 1235.20.406 Boehringer Ingelheim Investigational Site

    Barcelona,
    Spain

    Site Not Available

  • 1235.20.408 Boehringer Ingelheim Investigational Site

    Barcelona,
    Spain

    Site Not Available

  • 1235.20.402 Boehringer Ingelheim Investigational Site

    Granada,
    Spain

    Site Not Available

  • 1235.20.403 Boehringer Ingelheim Investigational Site

    Sevilla,
    Spain

    Site Not Available

  • 1235.20.409 Boehringer Ingelheim Investigational Site

    Valencia,
    Spain

    Site Not Available

  • 1235.20.451 Boehringer Ingelheim Investigational Site

    Kharkov,
    Ukraine

    Site Not Available

  • 1235.20.458 Boehringer Ingelheim Investigational Site

    Kharkov,
    Ukraine

    Site Not Available

  • 1235.20.460 Boehringer Ingelheim Investigational Site

    Kharkov,
    Ukraine

    Site Not Available

  • 1235.20.453 Boehringer Ingelheim Investigational Site

    Kiev,
    Ukraine

    Site Not Available

  • 1235.20.454 Boehringer Ingelheim Investigational Site

    Kiev,
    Ukraine

    Site Not Available

  • 1235.20.455 Boehringer Ingelheim Investigational Site

    Kiev,
    Ukraine

    Site Not Available

  • 1235.20.456 Boehringer Ingelheim Investigational Site

    Kiev,
    Ukraine

    Site Not Available

  • 1235.20.457 Boehringer Ingelheim Investigational Site

    Kiev,
    Ukraine

    Site Not Available

  • 1235.20.461 Boehringer Ingelheim Investigational Site

    Kiev,
    Ukraine

    Site Not Available

  • 1235.20.452 Boehringer Ingelheim Investigational Site

    Lvov,
    Ukraine

    Site Not Available

  • 1235.20.459 Boehringer Ingelheim Investigational Site

    Odessa,
    Ukraine

    Site Not Available

  • 1235.20.525 Boehringer Ingelheim Investigational Site

    Buena Park, California
    United States

    Site Not Available

  • 1235.20.503 Boehringer Ingelheim Investigational Site

    Long Beach, California
    United States

    Site Not Available

  • 1235.20.507 Boehringer Ingelheim Investigational Site

    Long Beach, California
    United States

    Site Not Available

  • 1235.20.529 Boehringer Ingelheim Investigational Site

    Roseville, California
    United States

    Site Not Available

  • 1235.20.518 Boehringer Ingelheim Investigational Site

    Tustin, California
    United States

    Site Not Available

  • 1235.20.521 Boehringer Ingelheim Investigational Site

    Westlake Village, California
    United States

    Site Not Available

  • 1235.20.508 Boehringer Ingelheim Investigational Site

    DeLand, Florida
    United States

    Site Not Available

  • 1235.20.506 Boehringer Ingelheim Investigational Site

    Hialeah, Florida
    United States

    Site Not Available

  • 1235.20.519 Boehringer Ingelheim Investigational Site

    Pembroke Pines, Florida
    United States

    Site Not Available

  • 1235.20.523 Boehringer Ingelheim Investigational Site

    Port Orange, Florida
    United States

    Site Not Available

  • 1235.20.528 Boehringer Ingelheim Investigational Site

    Blue Ridge, Georgia
    United States

    Site Not Available

  • 1235.20.516 Boehringer Ingelheim Investigational Site

    North Dartmouth, Massachusetts
    United States

    Site Not Available

  • 1235.20.527 Boehringer Ingelheim Investigational Site

    Bay City, Michigan
    United States

    Site Not Available

  • 1235.20.510 Boehringer Ingelheim Investigational Site

    Las Vegas, Nevada
    United States

    Site Not Available

  • 1235.20.512 Boehringer Ingelheim Investigational Site

    Albuquerque, New Mexico
    United States

    Site Not Available

  • 1235.20.509 Boehringer Ingelheim Investigational Site

    Bronx, New York
    United States

    Site Not Available

  • 1235.20.511 Boehringer Ingelheim Investigational Site

    Kettering, Ohio
    United States

    Site Not Available

  • 1235.20.515 Boehringer Ingelheim Investigational Site

    Tulsa, Oklahoma
    United States

    Site Not Available

  • 1235.20.534 Boehringer Ingelheim Investigational Site

    Medford, Oregon
    United States

    Site Not Available

  • 1235.20.526 Boehringer Ingelheim Investigational Site

    Erie, Pennsylvania
    United States

    Site Not Available

  • 1235.20.513 Boehringer Ingelheim Investigational Site

    Tipton, Pennsylvania
    United States

    Site Not Available

  • 1235.20.517 Boehringer Ingelheim Investigational Site

    Providence, Rhode Island
    United States

    Site Not Available

  • 1235.20.522 Boehringer Ingelheim Investigational Site

    Carrollton, Texas
    United States

    Site Not Available

  • 1235.20.520 Boehringer Ingelheim Investigational Site

    Houston, Texas
    United States

    Site Not Available

  • 1235.20.530 Boehringer Ingelheim Investigational Site

    Killeen, Texas
    United States

    Site Not Available

  • 1235.20.535 Boehringer Ingelheim Investigational Site

    Draper, Utah
    United States

    Site Not Available

  • 1235.20.533 Boehringer Ingelheim Investigational Site

    Magna, Utah
    United States

    Site Not Available

  • 1235.20.505 Boehringer Ingelheim Investigational Site

    Saratoga Springs, Utah
    United States

    Site Not Available

  • 1235.20.537 Boehringer Ingelheim Investigational Site

    Tacoma, Washington
    United States

    Site Not Available

  • 1235.20.501 Boehringer Ingelheim Investigational Site

    Madison, Wisconsin
    United States

    Site Not Available

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