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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
ClinicalTrials.gov Identifier:
NCT00860262
First received: March 11, 2009
Last updated: May 16, 2014
Last verified: May 2014
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
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
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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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
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 
Overall Participants Analyzed 
[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]
       
 49   37   26   112 
 133   67   78   278 
 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 ]

2.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6   [ Time Frame: baseline and week 6 ]

3.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4   [ Time Frame: baseline and week 4 ]

4.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2   [ Time Frame: baseline and week 2 ]

5.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1   [ Time Frame: baseline and week 1 ]

6.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8   [ Time Frame: baseline and week 8 ]

7.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6   [ Time Frame: baseline and week 6 ]

8.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4   [ Time Frame: baseline and week 4 ]

9.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2   [ Time Frame: baseline and week 2 ]

10.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1   [ Time Frame: baseline and week 1 ]

11.  Secondary:   Patients Achieving Diastolic Blood Pressure Control at Week 1   [ Time Frame: week 1 ]

12.  Secondary:   Patients Achieving Diastolic Blood Pressure Control at Week 2   [ Time Frame: week 2 ]

13.  Secondary:   Patients Achieving Blood Pressure Control at Week 1   [ Time Frame: week 1 ]

14.  Secondary:   Patients Achieving Blood Pressure Control at Week 2   [ Time Frame: week 2 ]

15.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 1   [ Time Frame: baseline, week 1 ]

16.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 2   [ Time Frame: baseline, week 2 ]

17.  Secondary:   Patients Achieving Systolic Blood Pressure Response at Week 1   [ Time Frame: baseline, week 1 ]

18.  Secondary:   Patients Achieving Systolic Blood Pressure Response at Week 2   [ Time Frame: baseline, week 2 ]

19.  Secondary:   Number of Patients Achieving Various Blood Pressure Response Levels at Week 1   [ Time Frame: week 1 ]

20.  Secondary:   Number of Patients Achieving Various Blood Pressure Response Levels at Week 2   [ Time Frame: week 2 ]

21.  Secondary:   Patients Achieving Diastolic Blood Pressure Control at Week 4   [ Time Frame: week 4 ]
  Hide Outcome Measure 21

Measure Type Secondary
Measure Title Patients Achieving Diastolic Blood Pressure Control at Week 4
Measure Description DBP < 90 mmHg
Time Frame week 4  
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.
FAS (LOCF)

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 
Participants Analyzed 
[Units: Participants]
 392   212   203 
Patients Achieving Diastolic Blood Pressure Control at Week 4 
[Units: Participants]
     
Controlled   268   106   109 
Not Controlled   124   106   94 

No statistical analysis provided for Patients Achieving Diastolic Blood Pressure Control at Week 4



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

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

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

25.  Secondary:   Patients Achieving Blood Pressure Control at Week 6   [ Time Frame: week 6 ]

26.  Secondary:   Patients Achieving Blood Pressure Control at Week 8   [ Time Frame: week 8 ]

27.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 4   [ Time Frame: baseline, week 4 ]

28.  Secondary:   Patients Achieving Diastolic Blood Pressure Response at Week 6   [ Time Frame: baseline, week 6 ]

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information