Open Label Study Telmisartan and Amlodipine in Hypertension

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00614380
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2009-03
• Results First Submitted: 2009-12-14
• Results First Submitted QC: 2009-12-14
• Results First Posted: 2010-01-18
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 976

Inclusion Criteria

1. patients aged at least 18 years
2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

Exclusion Criteria

1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study
2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
3. discontinuation from the preceding trial because of any adverse event or any other reason
4. known or suspected secondary hypertension
5. mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trough Seated Diastolic Blood Pressure (DBP) Control	End of study (34 weeks or last value on treatment)	The number of patients who reach the target DBP of \<90mmHg

Secondary Outcome Measures

Name	Time	Method
Trough Seated Systolic Blood Pressure (SBP) Control	End of study (34 weeks or last value on treatment)	The number of patients who reach the target SBP of \<140mmHg
Change From Baseline in Trough Seated Diastolic Blood Pressure	End of study (34 weeks or last value on treatment)	Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.
Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7	End of study (34 weeks or last value on treatment)	The difference between the last available troughs represents the additional reduction in DBP in this study
Change From Baseline in Trough Seated Systolic Blood Pressure	End of study (34 weeks or last value on treatment)	Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.
Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7	End of study (34 weeks or last value on treatment)	The difference between the last available troughs represents the additional reduction in SBP in this study
Trough Seated DBP Response	End of study (34 weeks or last value on treatment)	The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
Trough Seated SBP Response	End of study (34 weeks or last value on treatment)	The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
Trough Blood Pressure (BP) Normality Classes	End of study (34 weeks or last value on treatment)	The number of patients who reach predefined BP categories
Time to First Additional Antihypertensive	At any point during open-label treatment	Time from first intake of medication to first intake of an antihypertensive other than the study drug
Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control	At any point during open-label treatment	The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy	At any point during open-label treatment	Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy	At any point during open-label treatment	Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7
Trough DBP Control Pre- and Post- Uptitration	At any point during open-label treatment	The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration

Trial Locations

Locations (122)

1235.7.32004 Boehringer Ingelheim Investigational Site; 🇧🇪 Aywaille, Belgium

1235.7.32010 Boehringer Ingelheim Investigational Site; 🇧🇪 Gozée, Belgium

1235.7.32008 Boehringer Ingelheim Investigational Site; 🇧🇪 Linkebeek, Belgium

1235.7.32003 Boehringer Ingelheim Investigational Site; 🇧🇪 Mol, Belgium

1235.7.32007 Boehringer Ingelheim Investigational Site; 🇧🇪 Natoye, Belgium

1235.7.32002 Boehringer Ingelheim Investigational Site; 🇧🇪 Tienen, Belgium

1235.7.32005 Boehringer Ingelheim Investigational Site; 🇧🇪 Turnhout, Belgium

1235.7.20001 Boehringer Ingelheim Investigational Site; 🇨🇦 Coquitlam, British Columbia, Canada

1235.7.20011 Boehringer Ingelheim Investigational Site; 🇨🇦 Vancouver, British Columbia, Canada

1235.7.20007 Boehringer Ingelheim Investigational Site; 🇨🇦 Bay Roberts, Newfoundland and Labrador, Canada

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