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NCT00860262 Clinical Trial

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

Hypertension Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00860262
Other study ID # 1235.20
Secondary ID 2008-000873-40
Status Completed
Phase Phase 3
First received March 11, 2009
Last updated May 16, 2014
Start date March 2009

Study information
Verified date May 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Bulgarian Drug Agency, BG-1504 SofiaCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10France: AFFSAPSHungary: National Institute of Pharmacy, H-1051 BudapestKorea, Republic of: Korea Food and Drug Administration (KFDA)Romania: National Medicines Agency, BucharestRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26Spain: Agencia Española del medicamento y Productos Sanitarios (AEMPS) Subdirección General de Medicamentos de uso humano Parque empresarial las Mercedes, edificio 8 C/ Campezo, 1 28022 Madrid / SPAINUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 858
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• amlodipine
amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w
• telmisartan
telmisartan 80mg for the 8w, no titration required
• 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

Locations
Country Name City State
Bulgaria 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
Czech Republic 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
France 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
Hungary 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
Korea, Republic of 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
Romania 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
Russian Federation 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
Slovakia 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
Spain 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
Ukraine 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
United States 1235.20.512 Boehringer Ingelheim Investigational Site Albuquerque New Mexico
United States 1235.20.527 Boehringer Ingelheim Investigational Site Bay City Michigan
United States 1235.20.528 Boehringer Ingelheim Investigational Site Blue Ridge Georgia
United States 1235.20.509 Boehringer Ingelheim Investigational Site Bronx New York
United States 1235.20.525 Boehringer Ingelheim Investigational Site Buena Park California
United States 1235.20.522 Boehringer Ingelheim Investigational Site Carrollton Texas
United States 1235.20.508 Boehringer Ingelheim Investigational Site DeLand Florida
United States 1235.20.535 Boehringer Ingelheim Investigational Site Draper Utah
United States 1235.20.526 Boehringer Ingelheim Investigational Site Erie Pennsylvania
United States 1235.20.506 Boehringer Ingelheim Investigational Site Hialeah Florida
United States 1235.20.520 Boehringer Ingelheim Investigational Site Houston Texas
United States 1235.20.511 Boehringer Ingelheim Investigational Site Kettering Ohio
United States 1235.20.530 Boehringer Ingelheim Investigational Site Killeen Texas
United States 1235.20.510 Boehringer Ingelheim Investigational Site Las Vegas Nevada
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 1235.20.501 Boehringer Ingelheim Investigational Site Madison Wisconsin
United States 1235.20.533 Boehringer Ingelheim Investigational Site Magna Utah
United States 1235.20.534 Boehringer Ingelheim Investigational Site Medford Oregon
United States 1235.20.516 Boehringer Ingelheim Investigational Site North Dartmouth Massachusetts
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 1235.20.517 Boehringer Ingelheim Investigational Site Providence Rhode Island
United States 1235.20.529 Boehringer Ingelheim Investigational Site Roseville California
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 1235.20.513 Boehringer Ingelheim Investigational Site Tipton Pennsylvania
United States 1235.20.515 Boehringer Ingelheim Investigational Site Tulsa Oklahoma
United States 1235.20.518 Boehringer Ingelheim Investigational Site Tustin California
United States 1235.20.521 Boehringer Ingelheim Investigational Site Westlake Village California

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  France,  Hungary,  Korea, Republic of,  Romania,  Russian Federation,  Slovakia,  Spain,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 Overall mean reduction from a common mean baseline in SBP baseline and week 6 No
Secondary Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 Overall mean reduction from a common mean baseline in SBP baseline and week 4 No
Secondary Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 Overall mean reduction from a common mean baseline in SBP baseline and week 2 No
Secondary Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 Overall mean reduction from a common mean baseline in SBP baseline and week 1 No
Secondary Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 Overall mean reduction from a common mean baseline in DBP baseline and week 8 No
Secondary Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 Overall mean reduction from a common mean baseline in DBP baseline and week 6 No
Secondary Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 Overall mean reduction from a common mean baseline in DBP baseline and week 4 No
Secondary Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 Overall mean reduction from a common mean baseline in DBP baseline and week 2 No
Secondary Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 Overall mean reduction from a common mean baseline in DBP baseline and week 1 No
Secondary Patients Achieving Diastolic Blood Pressure Control at Week 1 Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg week 1 No
Secondary Patients Achieving Diastolic Blood Pressure Control at Week 2 DBP < 90 mmHg week 2 No
Secondary Patients Achieving Blood Pressure Control at Week 1 Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg week 1 No
Secondary Patients Achieving Blood Pressure Control at Week 2 SBP < 140 mmHg and DBP < 90 mmHg week 2 No
Secondary Patients Achieving Diastolic Blood Pressure Response at Week 1 Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg baseline, week 1 No
Secondary Patients Achieving Diastolic Blood Pressure Response at Week 2 DBP < 90 mmHg or reduction of >= 10 mmHg baseline, week 2 No
Secondary Patients Achieving Systolic Blood Pressure Response at Week 1 Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg baseline, week 1 No
Secondary Patients Achieving Systolic Blood Pressure Response at Week 2 SBP < 140 mmHg or reduction of >= 15 mmHg baseline, week 2 No
Secondary Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 week 1 No
Secondary Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 week 2 No
Secondary Patients Achieving Diastolic Blood Pressure Control at Week 4 DBP < 90 mmHg week 4 No
Secondary Patients Achieving Diastolic Blood Pressure Control at Week 6 DBP < 90 mmHg week 6 No
Secondary Patients Achieving Diastolic Blood Pressure Control at Week 8 DBP < 90 mmHg week 8 No
Secondary Patients Achieving Blood Pressure Control at Week 4 SBP < 140 mmHg and DBP < 90 mmHg week 4 No
Secondary Patients Achieving Blood Pressure Control at Week 6 SBP < 140 mmHg and DBP < 90 mmHg week 6 No
Secondary Patients Achieving Blood Pressure Control at Week 8 SBP < 140 mmHg and DBP < 90 mmHg week 8 No
Secondary Patients Achieving Diastolic Blood Pressure Response at Week 4 DBP < 90 mmHg or reduction of >= 10 mmHg baseline, week 4 No
Secondary Patients Achieving Diastolic Blood Pressure Response at Week 6 DBP < 90 mmHg or reduction of >= 10 mmHg baseline, week 6 No
Secondary Patients Achieving Diastolic Blood Pressure Response at Week 8 DBP < 90 mmHg or reduction of >= 10 mmHg baseline, week 8 No
Secondary Patients Achieving Systolic Blood Pressure Response at Week 4 SBP < 140 mmHg or reduction of >= 15 mmHg baseline, week 4 No
Secondary Patients Achieving Systolic Blood Pressure Response at Week 6 SBP < 140 mmHg or reduction of >= 15 mmHg baseline, week 6 No
Secondary Patients Achieving Systolic Blood Pressure Response at Week 8 SBP < 140 mmHg or reduction of >= 15 mmHg baseline, week 8 No
Secondary Patients Achieving Normal Blood Pressure Response at Week 4 Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 week 4 No
Secondary Patients Achieving Normal Blood Pressure Response at Week 6 Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 week 6 No
Secondary Patients Achieving Normal Blood Pressure Response at Week 8 Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 week 8 No
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External Links