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

NCT00860262 | Completed Phase 3 Results

• 2 other identifiers: 1235.202008-000873-40
• Study Type: interventional
• Target: 858
• Locations: 11 countries
• Sites: 137

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8

  Overall mean reduction from a common mean baseline in SBP

  baseline and week 8

Secondary Outcomes (34)

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

  baseline and week 6

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

  baseline and week 4

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

  baseline and week 2

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

  baseline and week 1

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

  baseline and week 8

Study Arms (3)

telmisartan and amlodipine

EXPERIMENTAL

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Drug: telmisartan and amlodipine

amlodipine

ACTIVE COMPARATOR

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Drug: amlodipine

telmisartan

ACTIVE COMPARATOR

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Drug: telmisartan

Interventions

amlodipine DRUG

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

amlodipine

telmisartan DRUG

telmisartan 80mg for the 8w, no titration required

telmisartan

telmisartan and amlodipine DRUG

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

telmisartan and amlodipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (137)

1235.20.525 Boehringer Ingelheim Investigational Site

Buena Park, California, United States

Location

1235.20.503 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1235.20.507 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1235.20.529 Boehringer Ingelheim Investigational Site

Roseville, California, United States

Location

1235.20.518 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Location

1235.20.521 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Location

1235.20.508 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1235.20.506 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Location

1235.20.519 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1235.20.523 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Location

1235.20.528 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

Location

1235.20.516 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1235.20.527 Boehringer Ingelheim Investigational Site

Bay City, Michigan, United States

Location

1235.20.510 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1235.20.512 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1235.20.509 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

1235.20.511 Boehringer Ingelheim Investigational Site

Kettering, Ohio, United States

Location

1235.20.515 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

1235.20.534 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

1235.20.526 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

Location

1235.20.513 Boehringer Ingelheim Investigational Site

Tipton, Pennsylvania, United States

Location

1235.20.517 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

Location

1235.20.522 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

Location

1235.20.520 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1235.20.530 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1235.20.535 Boehringer Ingelheim Investigational Site

Draper, Utah, United States

Location

1235.20.533 Boehringer Ingelheim Investigational Site

Magna, Utah, United States

Location

1235.20.505 Boehringer Ingelheim Investigational Site

Saratoga Springs, Utah, United States

Location

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

Location

1235.20.002 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

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1235.20.003 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.20.005 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.20.006 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.20.007 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.20.008 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.20.009 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.20.004 Boehringer Ingelheim Investigational Site

Stara Zagora, Bulgaria

Location

1235.20.052 Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, Czechia

Location

1235.20.059 Boehringer Ingelheim Investigational Site

Český Krumlov, Czechia

Location

1235.20.051 Boehringer Ingelheim Investigational Site

Pilsen, Czechia

Location

1235.20.053 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1235.20.054 Boehringer Ingelheim Investigational Site

Příbram, Czechia

Location

1235.20.055 Boehringer Ingelheim Investigational Site

Slaný, Czechia

Location

1235.20.057 Boehringer Ingelheim Investigational Site

Strakonice, Czechia

Location

1235.20.058 Boehringer Ingelheim Investigational Site

Tábor, Czechia

Location

1235.20.101A Boehringer Ingelheim Investigational Site

Albens, France

Location

1235.20.102F Boehringer Ingelheim Investigational Site

Arles, France

Location

1235.20.103A Boehringer Ingelheim Investigational Site

Béziers, France

Location

1235.20.103C Boehringer Ingelheim Investigational Site

Béziers, France

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1235.20.103F Boehringer Ingelheim Investigational Site

Béziers, France

Location

1235.20.106A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, France

Location

1235.20.109B Boehringer Ingelheim Investigational Site

Brivé, France

Location

1235.20.108E Boehringer Ingelheim Investigational Site

Carbonne, France

Location

1235.20.101D Boehringer Ingelheim Investigational Site

Chambéry, France

Location

1235.20.103E Boehringer Ingelheim Investigational Site

Cournonterral, France

Location

1235.20.108C Boehringer Ingelheim Investigational Site

Cugnaux, France

Location

1235.20.106D Boehringer Ingelheim Investigational Site

Étrelles, France

Location

1235.20.108F Boehringer Ingelheim Investigational Site

Fenouillet, France

Location

1235.20.102A Boehringer Ingelheim Investigational Site

Gémenos, France

Location

1235.20.102C Boehringer Ingelheim Investigational Site

Gémenos, France

Location

1235.20.101C Boehringer Ingelheim Investigational Site

Grésy-sur-Aix, France

Location

1235.20.108A Boehringer Ingelheim Investigational Site

Labarthe-sur-Lèze, France

Location

1235.20.108B Boehringer Ingelheim Investigational Site

Labarthe-sur-Lèze, France

Location

1235.20.106F Boehringer Ingelheim Investigational Site

Louvigné-de-Bais, France

Location

1235.20.102E Boehringer Ingelheim Investigational Site

Marseille, France

Location

1235.20.106B Boehringer Ingelheim Investigational Site

Mordelles, France

Location

1235.20.107A Boehringer Ingelheim Investigational Site

Orthez, France

Location

1235.20.107B Boehringer Ingelheim Investigational Site

Orthez, France

Location

1235.20.107E Boehringer Ingelheim Investigational Site

Orthez, France

Location

1235.20.107G Boehringer Ingelheim Investigational Site

Orthez, France

Location

1235.20.109A Boehringer Ingelheim Investigational Site

Rosiers-d'Égletons, France

Location

1235.20.109F Boehringer Ingelheim Investigational Site

Saint-Aulaire, France

Location

1235.20.104A Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1235.20.104D Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1235.20.107F Boehringer Ingelheim Investigational Site

Salies-de-Béarn, France

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1235.20.105A Boehringer Ingelheim Investigational Site

Toulon, France

Location

1235.20.105D Boehringer Ingelheim Investigational Site

Toulon, France

Location

1235.20.152 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1235.20.156 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1235.20.158 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1235.20.159 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1235.20.161 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1235.20.153 Boehringer Ingelheim Investigational Site

Gyöngyös, Hungary

Location

1235.20.154 Boehringer Ingelheim Investigational Site

Miskolc, Hungary

Location

1235.20.157 Boehringer Ingelheim Investigational Site

Miskolc, Hungary

Location

1235.20.155 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, Hungary

Location

1235.20.252 Boehringer Ingelheim Investigational Site

Brăila, Romania

Location

1235.20.259 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1235.20.262 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1235.20.254 Boehringer Ingelheim Investigational Site

Iași, Romania

Location

1235.20.261 Boehringer Ingelheim Investigational Site

Oradea, Romania

Location

1235.20.256 Boehringer Ingelheim Investigational Site

Sibiu, Romania

Location

1235.20.251 Boehringer Ingelheim Investigational Site

Târgu Mureş, Romania

Location

1235.20.260 Boehringer Ingelheim Investigational Site

Tg. Mures, Romania

Location

1235.20.253 Boehringer Ingelheim Investigational Site

Timișoara, Romania

Location

1235.20.301 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.20.302 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.20.303 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.20.304 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.20.310 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.20.305 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.20.306 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.20.307 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.20.308 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.20.309 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.20.311 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.20.355 Boehringer Ingelheim Investigational Site

Galanta, Slovakia

Location

1235.20.353 Boehringer Ingelheim Investigational Site

Košice, Slovakia

Location

1235.20.352 Boehringer Ingelheim Investigational Site

Považská Bystrica, Slovakia

Location

1235.20.354 Boehringer Ingelheim Investigational Site

Rimavská Sobota, Slovakia

Location

1235.20.356 Boehringer Ingelheim Investigational Site

Trnava, Slovakia

Location

1235.20.351 Boehringer Ingelheim Investigational Site

Vráble, Slovakia

Location

1235.20.207 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

1235.20.206 Boehringer Ingelheim Investigational Site

Junam, South Korea

Location

1235.20.205 Boehringer Ingelheim Investigational Site

Koyang, South Korea

Location

1235.20.201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.20.202 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.20.203 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.20.204 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.20.406 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1235.20.408 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1235.20.402 Boehringer Ingelheim Investigational Site

Granada, Spain

Location

1235.20.403 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1235.20.409 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1235.20.451 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.20.458 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.20.460 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.20.453 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.20.454 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.20.455 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.20.456 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.20.457 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.20.461 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.20.452 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1235.20.459 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Telmisartan; telmisartan amlodipine combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: May 20, 2014
• Results First Posted: January 4, 2011

Record last verified: 2014-05

Locations

UA (11); RO (9); CZ (8); US (30); FR (32); HU (9); BU (9); RU (11); SL (6); ES (5); KR (7)