Clinical trial NCT00860262: Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8
timeFrame: baseline and week 8
Secondary outcomes:
measure: Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6
timeFrame: baseline and week 6
measure: Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4
timeFrame: baseline and week 4
measure: Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2
timeFrame: baseline and week 2
measure: Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1
timeFrame: baseline and week 1
measure: Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8
timeFrame: baseline and week 8
measure: Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6
timeFrame: baseline and week 6
measure: Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4
timeFrame: baseline and week 4
measure: Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2
timeFrame: baseline and week 2
measure: Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1
timeFrame: baseline and week 1
measure: Patients Achieving Diastolic Blood Pressure Control at Week 1
timeFrame: week 1
measure: Patients Achieving Diastolic Blood Pressure Control at Week 2
timeFrame: week 2
measure: Patients Achieving Blood Pressure Control at Week 1
timeFrame: week 1
measure: Patients Achieving Blood Pressure Control at Week 2
timeFrame: week 2
measure: Patients Achieving Diastolic Blood Pressure Response at Week 1
timeFrame: baseline, week 1
measure: Patients Achieving Diastolic Blood Pressure Response at Week 2
timeFrame: baseline, week 2
measure: Patients Achieving Systolic Blood Pressure Response at Week 1
timeFrame: baseline, week 1
measure: Patients Achieving Systolic Blood Pressure Response at Week 2
timeFrame: baseline, week 2
measure: Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
timeFrame: week 1
measure: Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
timeFrame: week 2
measure: Patients Achieving Diastolic Blood Pressure Control at Week 4
timeFrame: week 4
measure: Patients Achieving Diastolic Blood Pressure Control at Week 6
timeFrame: week 6
measure: Patients Achieving Diastolic Blood Pressure Control at Week 8
timeFrame: week 8
measure: Patients Achieving Blood Pressure Control at Week 4
timeFrame: week 4
measure: Patients Achieving Blood Pressure Control at Week 6
timeFrame: week 6
measure: Patients Achieving Blood Pressure Control at Week 8
timeFrame: week 8
measure: Patients Achieving Diastolic Blood Pressure Response at Week 4
timeFrame: baseline, week 4
measure: Patients Achieving Diastolic Blood Pressure Response at Week 6
timeFrame: baseline, week 6
measure: Patients Achieving Diastolic Blood Pressure Response at Week 8
timeFrame: baseline, week 8
measure: Patients Achieving Systolic Blood Pressure Response at Week 4
timeFrame: baseline, week 4
measure: Patients Achieving Systolic Blood Pressure Response at Week 6
timeFrame: baseline, week 6
measure: Patients Achieving Systolic Blood Pressure Response at Week 8
timeFrame: baseline, week 8
measure: Patients Achieving Normal Blood Pressure Response at Week 4
timeFrame: week 4
measure: Patients Achieving Normal Blood Pressure Response at Week 6
timeFrame: week 6
measure: Patients Achieving Normal Blood Pressure Response at Week 8
timeFrame: week 8
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: 1235.20.525 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1235.20.503 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1235.20.507 Boehringer Ingelheim Investigational Site
state: California
city: Roseville
country: United States
facility: 1235.20.529 Boehringer Ingelheim Investigational Site
state: California
city: Tustin
country: United States
facility: 1235.20.518 Boehringer Ingelheim Investigational Site
state: California
city: Westlake Village
country: United States
facility: 1235.20.521 Boehringer Ingelheim Investigational Site
state: California
city: DeLand
country: United States
facility: 1235.20.508 Boehringer Ingelheim Investigational Site
state: Florida
city: Hialeah
country: United States
facility: 1235.20.506 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 1235.20.519 Boehringer Ingelheim Investigational Site
state: Florida
city: Port Orange
country: United States
facility: 1235.20.523 Boehringer Ingelheim Investigational Site
state: Florida
city: Blue Ridge
country: United States
facility: 1235.20.528 Boehringer Ingelheim Investigational Site
state: Georgia
city: North Dartmouth
country: United States
facility: 1235.20.516 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Bay City
country: United States
facility: 1235.20.527 Boehringer Ingelheim Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: 1235.20.510 Boehringer Ingelheim Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: 1235.20.512 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Bronx
country: United States
facility: 1235.20.509 Boehringer Ingelheim Investigational Site
state: New York
city: Kettering
country: United States
facility: 1235.20.511 Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 1235.20.515 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: 1235.20.534 Boehringer Ingelheim Investigational Site
state: Oregon
city: Erie
country: United States
facility: 1235.20.526 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Tipton
country: United States
facility: 1235.20.513 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: 1235.20.517 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Carrollton
country: United States
facility: 1235.20.522 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1235.20.520 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 1235.20.530 Boehringer Ingelheim Investigational Site
state: Texas
city: Draper
country: United States
facility: 1235.20.535 Boehringer Ingelheim Investigational Site
state: Utah
city: Magna
country: United States
facility: 1235.20.533 Boehringer Ingelheim Investigational Site
state: Utah
city: Saratoga Springs
country: United States
facility: 1235.20.505 Boehringer Ingelheim Investigational Site
state: Utah
city: Tacoma
country: United States
facility: 1235.20.537 Boehringer Ingelheim Investigational Site
state: Washington
city: Madison
country: United States
facility: 1235.20.501 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Bourgas
country: Bulgaria
facility: 1235.20.001 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.20.002 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.20.003 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.20.005 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.20.006 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.20.007 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.20.008 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.20.009 Boehringer Ingelheim Investigational Site
city: Stara Zagora
country: Bulgaria
facility: 1235.20.004 Boehringer Ingelheim Investigational Site
city: Benatky nad Jizerou
country: Czech Republic
facility: 1235.20.052 Boehringer Ingelheim Investigational Site
city: Cesky Krumlov
country: Czech Republic
facility: 1235.20.059 Boehringer Ingelheim Investigational Site
city: Plzen
country: Czech Republic
facility: 1235.20.051 Boehringer Ingelheim Investigational Site
city: Praha 5
country: Czech Republic
facility: 1235.20.053 Boehringer Ingelheim Investigational Site
city: Pribram
country: Czech Republic
facility: 1235.20.054 Boehringer Ingelheim Investigational Site
city: Slany
country: Czech Republic
facility: 1235.20.055 Boehringer Ingelheim Investigational Site
city: Strakonice
country: Czech Republic
facility: 1235.20.057 Boehringer Ingelheim Investigational Site
city: Tabor
country: Czech Republic
facility: 1235.20.058 Boehringer Ingelheim Investigational Site
city: Albens
country: France
facility: 1235.20.101A Boehringer Ingelheim Investigational Site
city: Arles
country: France
facility: 1235.20.102F Boehringer Ingelheim Investigational Site
city: Beziers
country: France
facility: 1235.20.103A Boehringer Ingelheim Investigational Site
city: Beziers
country: France
facility: 1235.20.103C Boehringer Ingelheim Investigational Site
city: Beziers
country: France
facility: 1235.20.103F Boehringer Ingelheim Investigational Site
city: Bourg des cptes
country: France
facility: 1235.20.106A Boehringer Ingelheim Investigational Site
city: Brive
country: France
facility: 1235.20.109B Boehringer Ingelheim Investigational Site
city: Carbonne
country: France
facility: 1235.20.108E Boehringer Ingelheim Investigational Site
city: Chambery
country: France
facility: 1235.20.101D Boehringer Ingelheim Investigational Site
city: Cournonterral
country: France
facility: 1235.20.103E Boehringer Ingelheim Investigational Site
city: Cugnaux
country: France
facility: 1235.20.108C Boehringer Ingelheim Investigational Site
city: Etrelles
country: France
facility: 1235.20.106D Boehringer Ingelheim Investigational Site
city: Fenouillet
country: France
facility: 1235.20.108F Boehringer Ingelheim Investigational Site
city: Gemenos
country: France
facility: 1235.20.102A Boehringer Ingelheim Investigational Site
city: Gemenos
country: France
facility: 1235.20.102C Boehringer Ingelheim Investigational Site
city: Gresy Sur Aix
country: France
facility: 1235.20.101C Boehringer Ingelheim Investigational Site
city: Labarthe Sur Leze
country: France
facility: 1235.20.108A Boehringer Ingelheim Investigational Site
city: Labarthe sur Leze
country: France
facility: 1235.20.108B Boehringer Ingelheim Investigational Site
city: Louvigne De bais
country: France
facility: 1235.20.106F Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1235.20.102E Boehringer Ingelheim Investigational Site
city: Mordelles
country: France
facility: 1235.20.106B Boehringer Ingelheim Investigational Site
city: Ortez
country: France
facility: 1235.20.107A Boehringer Ingelheim Investigational Site
city: Orthez
country: France
facility: 1235.20.107B Boehringer Ingelheim Investigational Site
city: Orthez
country: France
facility: 1235.20.107E Boehringer Ingelheim Investigational Site
city: Orthez
country: France
facility: 1235.20.107G Boehringer Ingelheim Investigational Site
city: Rosiers d'Egletons
country: France
facility: 1235.20.109A Boehringer Ingelheim Investigational Site
city: Saint Aulaire
country: France
facility: 1235.20.109F Boehringer Ingelheim Investigational Site
city: Saint Etienne
country: France
facility: 1235.20.104A Boehringer Ingelheim Investigational Site
city: Saint Etienne
country: France
facility: 1235.20.104D Boehringer Ingelheim Investigational Site
city: Salies de Bearn
country: France
facility: 1235.20.107F Boehringer Ingelheim Investigational Site
city: Toulon
country: France
facility: 1235.20.105A Boehringer Ingelheim Investigational Site
city: Toulon
country: France
facility: 1235.20.105D Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1235.20.152 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1235.20.156 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1235.20.158 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1235.20.159 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1235.20.161 Boehringer Ingelheim Investigational Site
city: Gyongyos
country: Hungary
facility: 1235.20.153 Boehringer Ingelheim Investigational Site
city: Miskolc
country: Hungary
facility: 1235.20.154 Boehringer Ingelheim Investigational Site
city: Miskolc
country: Hungary
facility: 1235.20.157 Boehringer Ingelheim Investigational Site
city: Mosonmagyarovar
country: Hungary
facility: 1235.20.155 Boehringer Ingelheim Investigational Site
city: Busan
country: Korea, Republic of
facility: 1235.20.207 Boehringer Ingelheim Investigational Site
city: Chunan
country: Korea, Republic of
facility: 1235.20.206 Boehringer Ingelheim Investigational Site
city: Koyang
country: Korea, Republic of
facility: 1235.20.205 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.20.201 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.20.202 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.20.203 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.20.204 Boehringer Ingelheim Investigational Site
city: Braila
country: Romania
facility: 1235.20.252 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1235.20.259 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1235.20.262 Boehringer Ingelheim Investigational Site
city: Iasi
country: Romania
facility: 1235.20.254 Boehringer Ingelheim Investigational Site
city: Oradea
country: Romania
facility: 1235.20.261 Boehringer Ingelheim Investigational Site
city: Sibiu
country: Romania
facility: 1235.20.256 Boehringer Ingelheim Investigational Site
city: Targu-Mures
country: Romania
facility: 1235.20.251 Boehringer Ingelheim Investigational Site
city: Tg. Mures
country: Romania
facility: 1235.20.260 Boehringer Ingelheim Investigational Site
city: Timisoara
country: Romania
facility: 1235.20.253 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.20.301 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.20.302 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.20.303 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.20.304 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.20.310 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.20.305 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.20.306 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.20.307 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.20.308 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.20.309 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.20.311 Boehringer Ingelheim Investigational Site
city: Galanta
country: Slovakia
facility: 1235.20.355 Boehringer Ingelheim Investigational Site
city: Kosice
country: Slovakia
facility: 1235.20.353 Boehringer Ingelheim Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: 1235.20.352 Boehringer Ingelheim Investigational Site
city: Rimavska Sobota
country: Slovakia
facility: 1235.20.354 Boehringer Ingelheim Investigational Site
city: Trnava
country: Slovakia
facility: 1235.20.356 Boehringer Ingelheim Investigational Site
city: Vrable
country: Slovakia
facility: 1235.20.351 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1235.20.406 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1235.20.408 Boehringer Ingelheim Investigational Site
city: Granada
country: Spain
facility: 1235.20.402 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1235.20.403 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1235.20.409 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.20.451 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.20.458 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.20.460 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.20.453 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.20.454 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.20.455 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.20.456 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.20.457 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.20.461 Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: 1235.20.452 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1235.20.459 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: