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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: amlodipine (Drug); telmisartan (Drug); telmisartan and amlodipine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

Official title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8

Secondary outcome:

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1

Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1

Patients Achieving Diastolic Blood Pressure Control at Week 1

Patients Achieving Diastolic Blood Pressure Control at Week 2

Patients Achieving Blood Pressure Control at Week 1

Patients Achieving Blood Pressure Control at Week 2

Patients Achieving Diastolic Blood Pressure Response at Week 1

Patients Achieving Diastolic Blood Pressure Response at Week 2

Patients Achieving Systolic Blood Pressure Response at Week 1

Patients Achieving Systolic Blood Pressure Response at Week 2

Number of Patients Achieving Various Blood Pressure Response Levels at Week 1

Number of Patients Achieving Various Blood Pressure Response Levels at Week 2

Patients Achieving Diastolic Blood Pressure Control at Week 4

Patients Achieving Diastolic Blood Pressure Control at Week 6

Patients Achieving Diastolic Blood Pressure Control at Week 8

Patients Achieving Blood Pressure Control at Week 4

Patients Achieving Blood Pressure Control at Week 6

Patients Achieving Blood Pressure Control at Week 8

Patients Achieving Diastolic Blood Pressure Response at Week 4

Patients Achieving Diastolic Blood Pressure Response at Week 6

Patients Achieving Diastolic Blood Pressure Response at Week 8

Patients Achieving Systolic Blood Pressure Response at Week 4

Patients Achieving Systolic Blood Pressure Response at Week 6

Patients Achieving Systolic Blood Pressure Response at Week 8

Patients Achieving Normal Blood Pressure Response at Week 4

Patients Achieving Normal Blood Pressure Response at Week 6

Patients Achieving Normal Blood Pressure Response at Week 8

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

1235.20.001 Boehringer Ingelheim Investigational Site, Bourgas, Bulgaria

1235.20.002 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

1235.20.003 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

1235.20.005 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

1235.20.006 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

1235.20.007 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

1235.20.008 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

1235.20.009 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

1235.20.004 Boehringer Ingelheim Investigational Site, Stara Zagora, Bulgaria

1235.20.052 Boehringer Ingelheim Investigational Site, Benatky nad Jizerou, Czech Republic

1235.20.059 Boehringer Ingelheim Investigational Site, Cesky Krumlov, Czech Republic

1235.20.051 Boehringer Ingelheim Investigational Site, Plzen, Czech Republic

1235.20.053 Boehringer Ingelheim Investigational Site, Praha 5, Czech Republic

1235.20.054 Boehringer Ingelheim Investigational Site, Pribram, Czech Republic

1235.20.055 Boehringer Ingelheim Investigational Site, Slany, Czech Republic

1235.20.057 Boehringer Ingelheim Investigational Site, Strakonice, Czech Republic

1235.20.058 Boehringer Ingelheim Investigational Site, Tabor, Czech Republic

1235.20.101A Boehringer Ingelheim Investigational Site, Albens, France

1235.20.102F Boehringer Ingelheim Investigational Site, Arles, France

1235.20.103A Boehringer Ingelheim Investigational Site, Beziers, France

1235.20.103C Boehringer Ingelheim Investigational Site, Beziers, France

1235.20.103F Boehringer Ingelheim Investigational Site, Beziers, France

1235.20.106A Boehringer Ingelheim Investigational Site, Bourg des cptes, France

1235.20.109B Boehringer Ingelheim Investigational Site, Brive, France

1235.20.108E Boehringer Ingelheim Investigational Site, Carbonne, France

1235.20.101D Boehringer Ingelheim Investigational Site, Chambery, France

1235.20.103E Boehringer Ingelheim Investigational Site, Cournonterral, France

1235.20.108C Boehringer Ingelheim Investigational Site, Cugnaux, France

1235.20.106D Boehringer Ingelheim Investigational Site, Etrelles, France

1235.20.108F Boehringer Ingelheim Investigational Site, Fenouillet, France

1235.20.102A Boehringer Ingelheim Investigational Site, Gemenos, France

1235.20.102C Boehringer Ingelheim Investigational Site, Gemenos, France

1235.20.101C Boehringer Ingelheim Investigational Site, Gresy Sur Aix, France

1235.20.108A Boehringer Ingelheim Investigational Site, Labarthe Sur Leze, France

1235.20.108B Boehringer Ingelheim Investigational Site, Labarthe sur Leze, France

1235.20.106F Boehringer Ingelheim Investigational Site, Louvigne De bais, France

1235.20.102E Boehringer Ingelheim Investigational Site, Marseille, France

1235.20.106B Boehringer Ingelheim Investigational Site, Mordelles, France

1235.20.107A Boehringer Ingelheim Investigational Site, Ortez, France

1235.20.107B Boehringer Ingelheim Investigational Site, Orthez, France

1235.20.107E Boehringer Ingelheim Investigational Site, Orthez, France

1235.20.107G Boehringer Ingelheim Investigational Site, Orthez, France

1235.20.109A Boehringer Ingelheim Investigational Site, Rosiers d'Egletons, France

1235.20.109F Boehringer Ingelheim Investigational Site, Saint Aulaire, France

1235.20.104A Boehringer Ingelheim Investigational Site, Saint Etienne, France

1235.20.104D Boehringer Ingelheim Investigational Site, Saint Etienne, France

1235.20.107F Boehringer Ingelheim Investigational Site, Salies de Bearn, France

1235.20.105A Boehringer Ingelheim Investigational Site, Toulon, France

1235.20.105D Boehringer Ingelheim Investigational Site, Toulon, France

1235.20.152 Boehringer Ingelheim Investigational Site, Budapest, Hungary

1235.20.156 Boehringer Ingelheim Investigational Site, Budapest, Hungary

1235.20.158 Boehringer Ingelheim Investigational Site, Budapest, Hungary

1235.20.159 Boehringer Ingelheim Investigational Site, Budapest, Hungary

1235.20.161 Boehringer Ingelheim Investigational Site, Budapest, Hungary

1235.20.153 Boehringer Ingelheim Investigational Site, Gyongyos, Hungary

1235.20.154 Boehringer Ingelheim Investigational Site, Miskolc, Hungary

1235.20.157 Boehringer Ingelheim Investigational Site, Miskolc, Hungary

1235.20.155 Boehringer Ingelheim Investigational Site, Mosonmagyarovar, Hungary

1235.20.207 Boehringer Ingelheim Investigational Site, Busan, Korea, Republic of

1235.20.206 Boehringer Ingelheim Investigational Site, Chunan, Korea, Republic of

1235.20.205 Boehringer Ingelheim Investigational Site, Koyang, Korea, Republic of

1235.20.201 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1235.20.202 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1235.20.203 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1235.20.204 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1235.20.252 Boehringer Ingelheim Investigational Site, Braila, Romania

1235.20.259 Boehringer Ingelheim Investigational Site, Bucharest, Romania

1235.20.262 Boehringer Ingelheim Investigational Site, Bucharest, Romania

1235.20.254 Boehringer Ingelheim Investigational Site, Iasi, Romania

1235.20.261 Boehringer Ingelheim Investigational Site, Oradea, Romania

1235.20.256 Boehringer Ingelheim Investigational Site, Sibiu, Romania

1235.20.251 Boehringer Ingelheim Investigational Site, Targu-Mures, Romania

1235.20.260 Boehringer Ingelheim Investigational Site, Tg. Mures, Romania

1235.20.253 Boehringer Ingelheim Investigational Site, Timisoara, Romania

1235.20.301 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

1235.20.302 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

1235.20.303 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

1235.20.304 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

1235.20.310 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

1235.20.305 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1235.20.306 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1235.20.307 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1235.20.308 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1235.20.309 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1235.20.311 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

1235.20.355 Boehringer Ingelheim Investigational Site, Galanta, Slovakia

1235.20.353 Boehringer Ingelheim Investigational Site, Kosice, Slovakia

1235.20.352 Boehringer Ingelheim Investigational Site, Povazska Bystrica, Slovakia

1235.20.354 Boehringer Ingelheim Investigational Site, Rimavska Sobota, Slovakia

1235.20.356 Boehringer Ingelheim Investigational Site, Trnava, Slovakia

1235.20.351 Boehringer Ingelheim Investigational Site, Vrable, Slovakia

1235.20.406 Boehringer Ingelheim Investigational Site, Barcelona, Spain

1235.20.408 Boehringer Ingelheim Investigational Site, Barcelona, Spain

1235.20.402 Boehringer Ingelheim Investigational Site, Granada, Spain

1235.20.403 Boehringer Ingelheim Investigational Site, Sevilla, Spain

1235.20.409 Boehringer Ingelheim Investigational Site, Valencia, Spain

1235.20.451 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine

1235.20.458 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine

1235.20.460 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine

1235.20.453 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1235.20.454 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1235.20.455 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1235.20.456 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1235.20.457 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1235.20.461 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1235.20.452 Boehringer Ingelheim Investigational Site, Lvov, Ukraine

1235.20.459 Boehringer Ingelheim Investigational Site, Odessa, Ukraine

1235.20.525 Boehringer Ingelheim Investigational Site, Buena Park, California, United States

1235.20.503 Boehringer Ingelheim Investigational Site, Long Beach, California, United States

1235.20.507 Boehringer Ingelheim Investigational Site, Long Beach, California, United States

1235.20.529 Boehringer Ingelheim Investigational Site, Roseville, California, United States

1235.20.518 Boehringer Ingelheim Investigational Site, Tustin, California, United States

1235.20.521 Boehringer Ingelheim Investigational Site, Westlake Village, California, United States

1235.20.508 Boehringer Ingelheim Investigational Site, DeLand, Florida, United States

1235.20.506 Boehringer Ingelheim Investigational Site, Hialeah, Florida, United States

1235.20.519 Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States

1235.20.523 Boehringer Ingelheim Investigational Site, Port Orange, Florida, United States

1235.20.528 Boehringer Ingelheim Investigational Site, Blue Ridge, Georgia, United States

1235.20.516 Boehringer Ingelheim Investigational Site, North Dartmouth, Massachusetts, United States

1235.20.527 Boehringer Ingelheim Investigational Site, Bay City, Michigan, United States

1235.20.510 Boehringer Ingelheim Investigational Site, Las Vegas, Nevada, United States

1235.20.512 Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States

1235.20.509 Boehringer Ingelheim Investigational Site, Bronx, New York, United States

1235.20.511 Boehringer Ingelheim Investigational Site, Kettering, Ohio, United States

1235.20.515 Boehringer Ingelheim Investigational Site, Tulsa, Oklahoma, United States

1235.20.534 Boehringer Ingelheim Investigational Site, Medford, Oregon, United States

1235.20.526 Boehringer Ingelheim Investigational Site, Erie, Pennsylvania, United States

1235.20.513 Boehringer Ingelheim Investigational Site, Tipton, Pennsylvania, United States

1235.20.517 Boehringer Ingelheim Investigational Site, Providence, Rhode Island, United States

1235.20.522 Boehringer Ingelheim Investigational Site, Carrollton, Texas, United States

1235.20.520 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

1235.20.530 Boehringer Ingelheim Investigational Site, Killeen, Texas, United States

1235.20.535 Boehringer Ingelheim Investigational Site, Draper, Utah, United States

1235.20.533 Boehringer Ingelheim Investigational Site, Magna, Utah, United States

1235.20.505 Boehringer Ingelheim Investigational Site, Saratoga Springs, Utah, United States

1235.20.537 Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States

1235.20.501 Boehringer Ingelheim Investigational Site, Madison, Wisconsin, United States

Additional Information

Starting date: March 2009
Last updated: May 16, 2014

Page last updated: August 23, 2015

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