TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch

Phase 3

Completed

• 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:

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2011-05
• Results First Submitted: 2012-05-31
• Results First Submitted QC: 2012-05-31
• Results First Posted: 2012-07-04
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

Not provided

Exclusion Criteria

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)

1235.33.49010 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

1235.33.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Frankfurt, Germany

1235.33.49007 Boehringer Ingelheim Investigational Site; 🇩🇪 Haag, 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

1235.33.49006 Boehringer Ingelheim Investigational Site; 🇩🇪 Rodgau-Dudenhofen, Germany

1235.33.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Unterschneidheim, Germany

1235.33.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Westerkappeln, Germany

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