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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00860262
First received: March 11, 2009
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
Results First Received: December 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: amlodipine
Drug: telmisartan
Drug: telmisartan and amlodipine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
T80+A10 Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
Telmisartan 80 mg Telmisartan 80 mg once daily (T80)
Amlodipine 10 mg Amlodipine 10 mg once daily (A10)

Participant Flow:   Overall Study
    T80+A10     Telmisartan 80 mg     Amlodipine 10 mg  
STARTED     421     217     220  
COMPLETED     401     195     202  
NOT COMPLETED     20     22     18  
Adverse Event                 9                 6                 7  
Protocol Violation                 0                 1                 0  
Lost to Follow-up                 2                 0                 1  
Withdrawal by Subject                 4                 8                 6  
Lack of Efficacy                 0                 4                 3  
Not Specified                 5                 3                 1  



  Baseline Characteristics
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Reporting Groups
  Description
T80+A10 Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
Telmisartan 80 mg Telmisartan 80 mg once daily (T80)
Amlodipine 10 mg Amlodipine 10 mg once daily (A10)
Total Total of all reporting groups

Baseline Measures
    T80+A10     Telmisartan 80 mg     Amlodipine 10 mg     Total  
Number of Participants  
[units: participants]
 		  421     217     220     858  
Age  
[units: years]
Mean ± Standard Deviation 		  58.0  ± 10.4     58.1  ± 10.2     58.6  ± 10.5     58.2  ± 10.3  
Age, Customized  
[units: Participants]
 		       
< 65 years     309     158     156     623  
>= 65 years     112     59     64     235  
Gender  
[units: participants]
 		       
Female     202     109     102     413  
Male     219     108     118     445  
Race/Ethnicity, Customized  
[units: participants]
 		       
White     362     186     190     738  
Black/African American     34     15     15     64  
Asian     20     14     14     48  
American Indian/Alaska Native     5     1     0     6  
Hawaiian/Pacific Islander     0     1     1     2  
Body Mass Index (BMI)  
[units: kilograms/square meter]
Mean ± Standard Deviation 		  30.6  ± 5.9     30.2  ± 5.2     30.7  ± 6.3     30.6  ± 5.8  
Body Mass Index Class  
[units: participants]
 		       
BMI < 25     63     31     35     129  
25 <= BMI < 30     160     79     82     321  
BMI >= 30     198     107     103     408  
Race Class  
[units: participants]
 		       
Non-Black     387     202     205     794  
Black     34     15     15     64  
Type II Diabetes  
[units: participants]
 		       
No     349     183     197     729  
Yes     72     34     23     129  
Duration of Hypertension  
[units: years]
Mean ± Standard Deviation 		  10.3  ± 9.6     9.4  ± 9.2     10.3  ± 10.1     10.1  ± 9.6  
Duration of Hypertension Class  
[units: participants]
 		       
< 1 year     38     25     20     83  
1 - 5 years     124     64     72     260  
6 - 10 years     103     61     54     218  
> 10 years     156     67     74     297  
Number of previous antihypertensive treatments  
[units: participants]
 		       
0     49     37     26     112  
1     133     67     78     278  
2     136     59     71     266  
>= 3     103     54     45     202  



  Outcome Measures
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1.  Primary:   Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8   [ Time Frame: baseline and week 8 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6   [ Time Frame: baseline and week 6 ]
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3.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4   [ Time Frame: baseline and week 4 ]
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4.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8   [ Time Frame: baseline and week 8 ]
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5.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6   [ Time Frame: baseline and week 6 ]
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6.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4   [ Time Frame: baseline and week 4 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2   [ Time Frame: baseline and week 2 ]
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8.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1   [ Time Frame: baseline and week 1 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2   [ Time Frame: baseline and week 2 ]
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10.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1   [ Time Frame: baseline and week 1 ]
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11.  Secondary:   Patients Achieving Diastolic Blood Pressure Control at Week 1   [ Time Frame: week 1 ]
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12.  Secondary:   Patients Achieving Diastolic Blood Pressure Control at Week 2   [ Time Frame: week 2 ]
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13.  Secondary:   Patients Achieving Blood Pressure Control at Week 1   [ Time Frame: week 1 ]
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14.  Secondary:   Patients Achieving Blood Pressure Control at Week 2   [ Time Frame: week 2 ]
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15.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 1   [ Time Frame: baseline, week 1 ]
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16.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 2   [ Time Frame: baseline, week 2 ]
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17.  Secondary:   Patients Achieving Systolic Blood Pressure Response at Week 1   [ Time Frame: baseline, week 1 ]
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18.  Secondary:   Patients Achieving Systolic Blood Pressure Response at Week 2   [ Time Frame: baseline, week 2 ]
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19.  Secondary:   Number of Patients Achieving Various Blood Pressure Response Levels at Week 1   [ Time Frame: week 1 ]
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20.  Secondary:   Number of Patients Achieving Various Blood Pressure Response Levels at Week 2   [ Time Frame: week 2 ]
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21.  Secondary:   Patients Achieving Diastolic Blood Pressure Control at Week 4   [ Time Frame: week 4 ]
  Show Outcome Measure 21

22.  Secondary:   Patients Achieving Diastolic Blood Pressure Control at Week 6   [ Time Frame: week 6 ]
  Show Outcome Measure 22

23.  Secondary:   Patients Achieving Diastolic Blood Pressure Control at Week 8   [ Time Frame: week 8 ]
  Show Outcome Measure 23

24.  Secondary:   Patients Achieving Blood Pressure Control at Week 4   [ Time Frame: week 4 ]
  Show Outcome Measure 24

25.  Secondary:   Patients Achieving Blood Pressure Control at Week 6   [ Time Frame: week 6 ]
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26.  Secondary:   Patients Achieving Blood Pressure Control at Week 8   [ Time Frame: week 8 ]
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27.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 4   [ Time Frame: baseline, week 4 ]
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28.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 6   [ Time Frame: baseline, week 6 ]
  Show Outcome Measure 28

29.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 8   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 29

30.  Secondary:   Patients Achieving Systolic Blood Pressure Response at Week 4   [ Time Frame: baseline, week 4 ]
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31.  Secondary:   Patients Achieving Systolic Blood Pressure Response at Week 6   [ Time Frame: baseline, week 6 ]
  Show Outcome Measure 31

32.  Secondary:   Patients Achieving Systolic Blood Pressure Response at Week 8   [ Time Frame: baseline, week 8 ]
  Hide Outcome Measure 32

Measure Type Secondary
Measure Title Patients Achieving Systolic Blood Pressure Response at Week 8
Measure Description SBP < 140 mmHg or reduction of >= 15 mmHg
Time Frame baseline, week 8  
Safety Issue No  

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.
Participants analyzed may vary from the Participant Flow due to the following. Participants are excluded for not having both a baseline and a post-baseline trough. Participants may be missing for not having data recorded during a time period. Participants may be missing from analysis if they discontinued from the study.

Reporting Groups
  Description
T80+A10 Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
Telmisartan 80 mg Telmisartan 80 mg once daily (T80)
Amlodipine 10 mg Amlodipine 10 mg once daily (A10)

Measured Values
    T80+A10     Telmisartan 80 mg     Amlodipine 10 mg  
Number of Participants Analyzed  
[units: participants]
 		  395     212     205  
Patients Achieving Systolic Blood Pressure Response at Week 8  
[units: participants]
 		     
Controlled     391     188     202  
Not Controlled     4     24     3  

No statistical analysis provided for Patients Achieving Systolic Blood Pressure Response at Week 8



33.  Secondary:   Patients Achieving Normal Blood Pressure Response at Week 4   [ Time Frame: week 4 ]
  Show Outcome Measure 33

34.  Secondary:   Patients Achieving Normal Blood Pressure Response at Week 6   [ Time Frame: week 6 ]
  Show Outcome Measure 34

35.  Secondary:   Patients Achieving Normal Blood Pressure Response at Week 8   [ Time Frame: week 8 ]
  Show Outcome Measure 35


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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
No text entered.  


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: NCT00860262     History of Changes
Other Study ID Numbers: 1235.20, 2008-000873-40
Study First Received: March 11, 2009
Results First Received: December 10, 2010
Last Updated: May 18, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
France: AFFSAPS
Hungary: National Institute of Pharmacy, H-1051 Budapest
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Romania: National Medicines Agency, Bucharest
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) Subdirección General de Medicamentos de uso humano Parque empresarial las Mercedes, edificio 8 C/ Campezo, 1 28022 Madrid / SPAIN
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration