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26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00624052
First received: February 5, 2008
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
Results First Received: December 28, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg
Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit
Randomised Telmisartan 80mg and Amlodipine 10mg Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
Titrated Telmisartan 80mg and Amlodipine 10mg Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit

Participant Flow:   Overall Study
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
STARTED     219     436     91     92  
COMPLETED     204     422     88     88  
NOT COMPLETED     15     14     3     4  
Adverse Event                 7                 6                 0                 3  
Lack of Efficacy                 1                 1                 0                 0  
Lost to Follow-up                 2                 3                 1                 0  
Non compliant with the protocol                 2                 1                 1                 1  
Consent withdrawn                 3                 1                 1                 0  
Changed job/ran out if meds                 0                 2                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.
Total Total of all reporting groups

Baseline Measures
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on     Total  
Number of Participants  
[units: participants]
 		  219     436     91     92     838  
Age  
[units: Years]
Mean ± Standard Deviation 		  56.2  ± 9.9     57.3  ± 9.4     55.2  ± 9.7     53.3  ± 10.3     56.4  ± 9.7  
Gender  
[units: Participants]
 		         
Female     93     206     31     37     367  
Male     126     230     60     55     471  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Trough Seated Diastolic Blood Pressure (DBP) Control   [ Time Frame: End of study (34 weeks or last value on treatment) ]

Measure Type Primary
Measure Title Trough Seated Diastolic Blood Pressure (DBP) Control
Measure Description The number of patients who reached the target DBP of <90mmHg
Time Frame End of study (34 weeks or last value on treatment)  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  216     436     91     92  
Trough Seated Diastolic Blood Pressure (DBP) Control  
[units: patients]
 		       
Yes (DBP<90 mmHg)     201     402     72     70  
No (DBP>=90 mmHg)     15     34     19     22  

No statistical analysis provided for Trough Seated Diastolic Blood Pressure (DBP) Control



2.  Secondary:   Trough Seated Systolic Blood Pressure (SBP) Control   [ Time Frame: End of study (34 weeks or last value on treatment) ]

Measure Type Secondary
Measure Title Trough Seated Systolic Blood Pressure (SBP) Control
Measure Description The number of patients who reached the target SBP of >=140mmHg
Time Frame End of study (34 weeks or last value on treatment)  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  216     436     91     92  
Trough Seated Systolic Blood Pressure (SBP) Control  
[units: patients]
 		       
Yes (SBP<140 mmHg)     179     366     70     51  
No (SBP>=140 mmHg)     37     70     21     41  

No statistical analysis provided for Trough Seated Systolic Blood Pressure (SBP) Control



3.  Secondary:   Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure   [ Time Frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment ]

Measure Type Secondary
Measure Title Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure
Measure Description No text entered.
Time Frame Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  214     434     87     91  
Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure  
[units: mmHg]
Least Squares Mean ± Standard Error 		  -13.41  ± 0.44     -13.36  ± 0.31     -11.52  ± 0.69     -10.64  ± 0.67  

No statistical analysis provided for Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure



4.  Secondary:   Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052   [ Time Frame: Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment) ]

Measure Type Secondary
Measure Title Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Measure Description The difference between the last available troughs represents the additional reduction in DBP in this study
Time Frame Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  213     430     91     92  
Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052  
[units: mmHg]
Least Squares Mean ± Standard Error 		  -4.36  ± 0.48     -4.97  ± 0.34     -5.51  ± 0.74     -5.43  ± 0.73  

No statistical analysis provided for Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052



5.  Secondary:   Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure   [ Time Frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment ]

Measure Type Secondary
Measure Title Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure
Measure Description No text entered.
Time Frame Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  214     434     87     91  
Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure  
[units: mmHg]
Least Squares Mean ± Standard Error 		  -14.76  ± 0.72     -15.93  ± 0.5     -14.85  ± 1.12     -12.44  ± 1.1  

No statistical analysis provided for Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure



6.  Secondary:   Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052   [ Time Frame: Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment) ]

Measure Type Secondary
Measure Title Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Measure Description The difference between the last available troughs represents the additional reduction in SBP in this study
Time Frame Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  213     430     91     92  
Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052  
[units: mmHg]
Least Squares Mean ± Standard Error 		  -4.73  ± 0.73     -6.02  ± 0.51     -6.55  ± 1.11     -5.61  ± 1.1  

No statistical analysis provided for Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052



7.  Secondary:   Trough Seated DBP Response   [ Time Frame: End of study (34 weeks or last value on treatment) ]

Measure Type Secondary
Measure Title Trough Seated DBP Response
Measure Description The number of patients who reach the target DBP of >=90mmHg or had a reduction in DBP >= 10mmHg
Time Frame End of study (34 weeks or last value on treatment)  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  214     434     87     91  
Trough Seated DBP Response  
[units: patients]
 		       
Yes (Responder)     201     405     71     73  
No (Non-responder)     13     29     16     18  

No statistical analysis provided for Trough Seated DBP Response



8.  Secondary:   Trough Seated SBP Response   [ Time Frame: End of study (34 weeks or last value on treatment) ]

Measure Type Secondary
Measure Title Trough Seated SBP Response
Measure Description The number of patients who reach the target SBP of >=140mmHg or had a reduction in SBP >= 15 mmHg
Time Frame End of study (34 weeks or last value on treatment)  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  214     434     87     91  
Trough Seated SBP Response  
[units: patients]
 		       
Yes (Responder)     190     401     75     69  
No (Non-responder)     24     33     12     22  

No statistical analysis provided for Trough Seated SBP Response



9.  Secondary:   Trough BP Normality Classes   [ Time Frame: End of study (34 weeks or last value on treatment) ]

Measure Type Secondary
Measure Title Trough BP Normality Classes
Measure Description The number of patients who reach predefined BP categories
Time Frame End of study (34 weeks or last value on treatment)  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.
Randomised Telmisartan 80mg and Amlodipine 10mg No text entered.
Titrated Telmisartan 80mg and Amlodipine 10mg No text entered.
Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg     Randomised Telmisartan 80mg and Amlodipine 10mg     Titrated Telmisartan 80mg and Amlodipine 10mg     Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on  
Number of Participants Analyzed  
[units: participants]
 		  213     430     91     92  
Trough BP Normality Classes  
[units: patients]
 		       
Optimal (SBP<120 and DBP<80 mmHg)     12     20     5     3  
Normal (SBP<130 and DBP<85 mmHg and not optimal)     70     146     14     13  
High-normal (SBP<140 DBP<90 mmHg and not normal)     94     189     46     29  
Stage 1 hypertension (SBP<160 and DBP<100 mmHg     32     76     23     43  
Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg)     8     5     3     4  

No statistical analysis provided for Trough BP Normality Classes



10.  Secondary:   Time to First Additional Antihypertensive   [ Time Frame: up to 34 weeks ]

Measure Type Secondary
Measure Title Time to First Additional Antihypertensive
Measure Description Time from first intake of medication to first intake of an antihypertensive other than the study drug
Time Frame up to 34 weeks  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg  
Number of Participants Analyzed  
[units: participants]
 		  121  
Time to First Additional Antihypertensive  
[units: Days]
Mean ± Standard Deviation 		  91.9  ± 45.2  

No statistical analysis provided for Time to First Additional Antihypertensive



11.  Secondary:   Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control   [ Time Frame: up to 34 weeks ]

Measure Type Secondary
Measure Title Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Measure Description 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
Time Frame up to 34 weeks  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

Reporting Groups
  Description
Pre-antihypertensive: Yes (DBP<90 mmHg) No text entered.
Pre-antihypertensive: No (DBP>=90 mmHg) No text entered.
Pre-antihypertensive: Total No text entered.

Measured Values
    Pre-antihypertensive: Yes (DBP<90 mmHg)     Pre-antihypertensive: No (DBP>=90 mmHg)     Pre-antihypertensive: Total  
Number of Participants Analyzed  
[units: participants]
 		  31     90     121  
Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control  
[units: patients]
 		     
Post-antihypertensive: Yes (DBP<90 mmHg)     27     67     94  
Post-antihypertensive: No (DBP>=90 mmHg)     4     23     27  
Post-antihypertensive: Total     31     90     121  

No statistical analysis provided for Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control



12.  Secondary:   Additional Reduction in DBP by Use of Additional Antihypertensive Therapy   [ Time Frame: up to 34 weeks ]

Measure Type Secondary
Measure Title Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Measure Description Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052
Time Frame up to 34 weeks  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg  
Number of Participants Analyzed  
[units: participants]
 		  121  
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy  
[units: mmHg]
Mean ± Standard Deviation 		  -6.79  ± 7.39  

No statistical analysis provided for Additional Reduction in DBP by Use of Additional Antihypertensive Therapy



13.  Secondary:   Additional Reduction in SBP by Use of Additional Antihypertensive Therapy   [ Time Frame: up to 34 weeks ]

Measure Type Secondary
Measure Title Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Measure Description Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052
Time Frame up to 34 weeks  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Total for the full analysis set

Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 10mg No text entered.

Measured Values
    Telmisartan 40mg and Amlodipine 10mg  
Number of Participants Analyzed  
[units: participants]
 		  121  
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy  
[units: mmHg]
Mean ± Standard Deviation 		  -7.79  ± 12.37  

No statistical analysis provided for Additional Reduction in SBP by Use of Additional Antihypertensive Therapy



14.  Secondary:   Trough DBP Control Pre- and Post- Uptitration   [ Time Frame: up to 34 weeks ]

Measure Type Secondary
Measure Title Trough DBP Control Pre- and Post- Uptitration
Measure Description The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.
Time Frame up to 34 weeks  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.

Reporting Groups
  Description
Pre-titration: Yes (DBP<90 mmHg) No text entered.
Pre-titration: No (DBP>=90 mmHg) No text entered.
Pre-titration: Total No text entered.

Measured Values
    Pre-titration: Yes (DBP<90 mmHg)     Pre-titration: No (DBP>=90 mmHg)     Pre-titration: Total  
Number of Participants Analyzed  
[units: participants]
 		  324     258     582  
Trough DBP Control Pre- and Post- Uptitration  
[units: patients]
 		     
Post-titration: Yes (DBP<90 mmHg)     306     168     474  
Post-titration: No (DBP>=90 mmHg)     18     90     108  
Post-titration: Total     324     258     582  

No statistical analysis provided for Trough DBP Control Pre- and Post- Uptitration




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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00624052     History of Changes
Other Study ID Numbers: 1235.8
Study First Received: February 5, 2008
Results First Received: December 28, 2009
Last Updated: July 10, 2012
Health Authority: Australia: Responsilble Ethics Committee
Austria: Federal Office for Safety in Health Care
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Great Britain: MHRA
Ireland: Irish Medicines Board
Italy: Comitato Etico della prov. Di Ferrara
New Zealand: Multicentre Ethics Committee/Medsafe
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS)
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)