TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch
- Conditions
- Hypertension
- Interventions
- Drug: telmisartan/amlodipine
- Registration Number
- NCT01134393
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.
- Detailed Description
Study Design:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description telmisartan/amlodipine telmisartan/amlodipine start low dose and uptitrate to high dose on the basis of blood pressure goal
- Primary Outcome Measures
Name Time Method Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. 12 weeks Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.
- Secondary Outcome Measures
Name Time Method BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. 4 and 8 weeks Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.
BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). Week 12 Achieving BP control with HBPM is defined as SBP\<135 mmHg and DBP\<85 mmHg.
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP weeks 4, 8 and 12 Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate weeks 4, 8 and 12 Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.
Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure weeks 4, 8 and 12 DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements weeks 4, 8 and 12 DBP control is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP \<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=10mmHg. SBP response is defined as SBP\<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=15mmHg.
Percentage of Patients in Blood Pressure Categories Over Time weeks 4, 8 and 12 BP optimal: SBP \<120 mmHg and DBP \<80 mmHg, BP normal: SBP \<130 mmHg and DBP \<85 mmHg but not optimal, BP high-normal: SBP \<140 mmHg and DBP \<90 mmHg but not normal. Grade 1 hypertension: SBP \<160 mmHg and DBP \<100 mmHg but not high-normal, Grade 2 hypertension: SBP \<180 mmHg and DBP \<110 mmHg but not grade 1, Grade 3 hypertension: SBP \>=180 mmHg or DBP \>=110 mmHg.
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements weeks 4, 8 and 12 DBP control: DBP \<85 mmHg, SBP control: SBP \<135 mmHg, DBP response: DBP \<85 mmHg or a reduction from baseline \>=10 mmHg, SBP response: SBP \<135 mmHg or a reduction from baseline \>= 15 mmHg
Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time weeks 4 and 8
Trial Locations
- Locations (47)
1235.33.39009 Boehringer Ingelheim Investigational Site
🇮🇹Arezzo, Italy
1235.33.39002 Boehringer Ingelheim Investigational Site
🇮🇹Bologna, Italy
1235.33.49010 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1235.33.49007 Boehringer Ingelheim Investigational Site
🇩🇪Haag, Germany
1235.33.49002 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt, Germany
1235.33.49003 Boehringer Ingelheim Investigational Site
🇩🇪Heidelberg, Germany
1235.33.49005 Boehringer Ingelheim Investigational Site
🇩🇪Künzing, Germany
1235.33.49008 Boehringer Ingelheim Investigational Site
🇩🇪Nürnberg, Germany
1235.33.49009 Boehringer Ingelheim Investigational Site
🇩🇪Rednitzhembach, Germany
1235.33.49004 Boehringer Ingelheim Investigational Site
🇩🇪Unterschneidheim, Germany
1235.33.49006 Boehringer Ingelheim Investigational Site
🇩🇪Rodgau-Dudenhofen, Germany
1235.33.49001 Boehringer Ingelheim Investigational Site
🇩🇪Westerkappeln, Germany
1235.33.39004 Boehringer Ingelheim Investigational Site
🇮🇹Ferrara, Italy
1235.33.39001 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
1235.33.39006 Boehringer Ingelheim Investigational Site
🇮🇹L'Aquila, Italy
1235.33.39008 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1235.33.39007 Boehringer Ingelheim Investigational Site
🇮🇹Napoli, Italy
1235.33.39005 Boehringer Ingelheim Investigational Site
🇮🇹Stradella (PV), Italy
1235.33.52004 Boehringer Ingelheim Investigational Site
🇲🇽Aguascalientes, Mexico
1235.33.52007 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1235.33.52002 Boehringer Ingelheim Investigational Site
🇲🇽Durango, Mexico
1235.33.52008 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
1235.33.31009 Boehringer Ingelheim Investigational Site
🇳🇱Almere, Netherlands
1235.33.31007 Boehringer Ingelheim Investigational Site
🇳🇱's Hertogenbosch, Netherlands
1235.33.31005 Boehringer Ingelheim Investigational Site
🇳🇱Beek en Donk, Netherlands
1235.33.31002 Boehringer Ingelheim Investigational Site
🇳🇱Beerzerveld, Netherlands
1235.33.31008 Boehringer Ingelheim Investigational Site
🇳🇱Ermelo, Netherlands
1235.33.31001 Boehringer Ingelheim Investigational Site
🇳🇱Musselkanaal, Netherlands
1235.33.31003 Boehringer Ingelheim Investigational Site
🇳🇱Wildervank, Netherlands
1235.33.31006 Boehringer Ingelheim Investigational Site
🇳🇱Lichtenvoorde, Netherlands
1235.33.31004 Boehringer Ingelheim Investigational Site
🇳🇱Nijverdal, Netherlands
1235.33.48005 Boehringer Ingelheim Investigational Site
🇵🇱Chorzow, Poland
1235.33.48002 Boehringer Ingelheim Investigational Site
🇵🇱Czestochowa, Poland
1235.33.48003 Boehringer Ingelheim Investigational Site
🇵🇱Czestochowa, Poland
1235.33.48006 Boehringer Ingelheim Investigational Site
🇵🇱Grodzisk Mazowiecki, Poland
1235.33.48013 Boehringer Ingelheim Investigational Site
🇵🇱Oswiecim, Poland
1235.33.48004 Boehringer Ingelheim Investigational Site
🇵🇱Poznan, Poland
1235.33.48008 Boehringer Ingelheim Investigational Site
🇵🇱Piotrkow Trybunalski, Poland
1235.33.48001 Boehringer Ingelheim Investigational Site
🇵🇱Tychy, Poland
1235.33.52001 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1235.33.48009 Boehringer Ingelheim Investigational Site
🇵🇱Tychy, Poland
1235.33.52006 Boehringer Ingelheim Investigational Site
🇲🇽Mexico, Mexico
1235.33.48010 Boehringer Ingelheim Investigational Site
🇵🇱Dabrowa Gornicza, Poland
1235.33.48007 Boehringer Ingelheim Investigational Site
🇵🇱Wroclaw, Poland
1235.33.52003 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1235.33.52009 Boehringer Ingelheim Investigational Site
🇲🇽Mexico, Mexico
1235.33.48011 Boehringer Ingelheim Investigational Site
🇵🇱Warszawa, Poland