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Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00281580
First received: January 24, 2006
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
Results First Received: November 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Amlodipine 5 mg
Drug: Placebo
Drug: Telmisartan 20 mg
Drug: Telmisartan 40 mg
Drug: Amlodipine 10 mg
Drug: Telmisartan 80 mg
Drug: Amlodipine 2.5 mg

  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
Placebo (Pl) placebo tablet plus encapsulated placebo tablet, QD in morning
Telmisartan 20 mg (T20) Telmisartan 20mg tablet, QD in morning
Telmisartan 40 mg (T40) Telmisartan 40mg tablet, QD in morning
Telmisartan 80 mg (T80) Telmisartan 80mg tablet, QD in morning
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) T20mg tab plus encapsulated A2.5mg capsule, QD in morning
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) T20mg tab plus encapsulated A5mg capsule, QD in morning
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) T40mg tab plus encapsulated A2.5mg capsule, QD in morning
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) T40mg tab plus encapsulated A5mg capsule, QD in morning
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) T80mg tab plus encapsulated A2.5mg capsule, QD in morning
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) T80mg tab plus encapsulated A5mg capsule, QD in morning
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
Amlodipine 2.5 mg (A2.5) encapsulated Amlodipine 2.5 mg capsule, QD in morning
Amlodipine 5 mg (A5) encapsulated Amlodipine 5 mg capsule, QD in morning
Amlodipine 10 mg (A10) 2 encapsulated Amlodipine 5 mg capsule, QD in morning

Participant Flow:   Overall Study
    Placebo (Pl)     Telmisartan 20 mg (T20)     Telmisartan 40 mg (T40)     Telmisartan 80 mg (T80)     Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)     Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)     Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)     Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)     Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)     Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)     Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)     Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)     Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)     Amlodipine 2.5 mg (A2.5)     Amlodipine 5 mg (A5)     Amlodipine 10 mg (A10)  
STARTED     46     42     130     135     44     46     44     47     143     129     48     146     142     50     140     129  
COMPLETED     39     41     125     118     40     43     39     46     135     117     44     136     129     43     133     116  
NOT COMPLETED     7     1     5     17     4     3     5     1     8     12     4     10     13     7     7     13  
Adverse Event                 2                 0                 2                 4                 1                 0                 1                 0                 1                 6                 0                 5                 8                 2                 3                 3  
Protocol Violation                 0                 0                 1                 1                 0                 0                 1                 0                 2                 0                 1                 2                 0                 1                 1                 3  
Withdrawal by Subject                 3                 0                 1                 1                 1                 2                 2                 0                 1                 4                 1                 1                 2                 2                 1                 5  
Lack of Efficacy                 2                 1                 1                 6                 2                 0                 0                 0                 0                 0                 0                 1                 0                 2                 1                 0  
Lost to Follow-up                 0                 0                 0                 3                 0                 1                 0                 1                 2                 1                 1                 0                 1                 0                 0                 0  
Randomised in error; prenancy; moving                 0                 0                 0                 2                 0                 0                 1                 0                 2                 1                 1                 1                 2                 0                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo (Pl) placebo tablet plus encapsulated placebo tablet, QD in morning
Telmisartan 20 mg (T20) Telmisartan 20mg tablet, QD in morning
Telmisartan 40 mg (T40) Telmisartan 40mg tablet, QD in morning
Telmisartan 80 mg (T80) Telmisartan 80mg tablet, QD in morning
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) T20mg tab plus encapsulated A2.5mg capsule, QD in morning
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) T20mg tab plus encapsulated A5mg capsule, QD in morning
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) T40mg tab plus encapsulated A2.5mg capsule, QD in morning
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) T40mg tab plus encapsulated A5mg capsule, QD in morning
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) T80mg tab plus encapsulated A2.5mg capsule, QD in morning
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) T80mg tab plus encapsulated A5mg capsule, QD in morning
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
Amlodipine 2.5 mg (A2.5) encapsulated Amlodipine 2.5 mg capsule, QD in morning
Amlodipine 5 mg (A5) encapsulated Amlodipine 5 mg capsule, QD in morning
Amlodipine 10 mg (A10) 2 encapsulated Amlodipine 5 mg capsule, QD in morning
Total Total of all reporting groups

Baseline Measures
    Placebo (Pl)     Telmisartan 20 mg (T20)     Telmisartan 40 mg (T40)     Telmisartan 80 mg (T80)     Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)     Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)     Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)     Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)     Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)     Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)     Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)     Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)     Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)     Amlodipine 2.5 mg (A2.5)     Amlodipine 5 mg (A5)     Amlodipine 10 mg (A10)     Total  
Number of Participants  
[units: participants]
 		  46     42     130     135     44     46     44     47     143     129     48     146     142     50     140     129     1461  
Age  
[units: Years]
Mean ± Standard Deviation 		  52.5  ± 12.3     53.6  ± 10.4     52  ± 11     53.1  ± 11.3     54  ± 10.8     54.4  ± 10.2     51  ± 11.2     50.7  ± 10.2     52.3  ± 11.9     53.3  ± 11.3     54.8  ± 9.7     52.7  ± 11.9     53.9  ± 11.6     55.3  ± 10.4     53.1  ± 10.6     53.4  ± 10.7     53.1  ± 11.1  
Gender  
[units: Participants]
 		                                 
Female     17     16     64     75     18     25     18     21     72     67     26     72     78     23     68     64     724  
Male     29     26     66     60     26     21     26     26     71     62     22     74     64     27     72     65     737  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF)) ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 2

3.  Primary:   Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 3

4.  Primary:   Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 4

5.  Primary:   Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)   [ Time Frame: End-of-study visit (LOCF) ]
  Show Outcome Measure 5

6.  Primary:   Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups)   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 6

7.  Primary:   Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 7

8.  Primary:   Change From Baseline in Seated Trough Cuff Mean DBP   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 8

9.  Primary:   Change From Baseline in Seated Trough Cuff Mean DBP   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 9

10.  Primary:   Change From Baseline in Seated Trough Cuff Mean DBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 10

11.  Primary:   Change From Baseline in Seated Trough Cuff Mean DBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 11

12.  Primary:   Change From Baseline in Seated Trough Cuff Mean DBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 12

13.  Primary:   Change From Baseline in Seated Trough Cuff Mean DBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 13

14.  Primary:   Change From Baseline in Seated Trough Cuff Mean DBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline at 8 Weeks in Seated Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups)   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups)   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups)   [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP (Observed Treatment Effects)   [ Time Frame: Baseline to nominal week over the trial ]
  Show Outcome Measure 18

19.  Secondary:   DBP Control   [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 19

20.  Secondary:   DBP Response   [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 20

21.  Secondary:   SBP Response   [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 21

22.  Secondary:   BP Control   [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 22

23.  Secondary:   BP Normality   [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 23

24.  Secondary:   Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP (Observed Treatment Effects)   [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 24

25.  Secondary:   Change From Baseline in ABPM 24-hour Mean DBP (Observed Treatment Effects)   [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 25

26.  Secondary:   Change From Baseline in ABPM 24-hour Mean SBP (Observed Treatment Effects)   [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ]
  Show Outcome Measure 26

27.  Secondary:   Orthostatic Change in Trough Cuff Mean DBP   [ Time Frame: Week 8 ]
  Show Outcome Measure 27

28.  Secondary:   Orthostatic Change in Trough Cuff Mean SBP   [ Time Frame: Week 8 ]
  Show Outcome Measure 28

29.  Secondary:   Change From Baseline in Seated Trough Pulse Rate   [ Time Frame: End-of-study visit (LOCF) ]
  Show Outcome Measure 29

30.  Secondary:   Change From Baseline in Seated Trough Cuff Mean SBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 30

31.  Secondary:   Change From Baseline in Standing Trough Cuff Mean DBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 31

32.  Secondary:   Change From Baseline in Standing Trough Cuff Mean SBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 32

33.  Secondary:   Change From Baseline in Seated Trough Cuff DBP   [ Time Frame: Nominal week over the trial ]
  Hide Outcome Measure 33

Measure Type Secondary
Measure Title Change From Baseline in Seated Trough Cuff DBP
Measure Description Observed results for mod-sev patients - key combination therapies
Time Frame Nominal week over the trial  
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 40 mg Plus Amlodipine 5 mg (T40+A5) No text entered.
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) No text entered.
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) No text entered.
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) No text entered.

Measured Values
    Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)     Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)     Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)     Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)  
Number of Participants Analyzed  
[units: participants]
 		  108     96     106     100  
Change From Baseline in Seated Trough Cuff DBP  
[units: mmHg]
Mean ± Standard Deviation 		       
Week 2     -14.7  ± 8.9     -14.7  ± 7.8     -16.1  ± 7.9     -14.9  ± 6.7  
Week 4     -16.5  ± 6.8     -18.2  ± 9.2     -17.8  ± 7.6     -19.2  ± 6.8  
Week 6     -17.9  ± 7.8     -19.7  ± 8.7     -18.9  ± 8.2     -19.5  ± 8.4  
Week 8     -17.1  ± 7.4     -19.4  ± 8.5     -19.3  ± 8.7     -21.1  ± 7.1  

No statistical analysis provided for Change From Baseline in Seated Trough Cuff DBP



34.  Secondary:   DBP Control   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 34

35.  Secondary:   DBP Response   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 35

36.  Secondary:   SBP Response   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 36

37.  Secondary:   BP Control   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 37

38.  Secondary:   BP Normality   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 38

39.  Secondary:   Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 39

40.  Secondary:   Change From Baseline in ABPM 24-hour Mean DBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 40

41.  Secondary:   Change From Baseline in ABPM 24-hour Mean SBP   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 41

42.  Secondary:   Orthostatic Change in Trough Cuff Mean DBP   [ Time Frame: Week 8 ]
  Show Outcome Measure 42

43.  Secondary:   Orthostatic Change in Trough Cuff Mean SBP   [ Time Frame: Week 8 ]
  Show Outcome Measure 43

44.  Secondary:   Change From Baseline in Seated Trough Pulse Rate   [ Time Frame: Up to 8 weeks (LOCF) ]
  Show Outcome Measure 44


  Serious Adverse Events
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  Other Adverse Events
  Show Other Adverse Events


  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 Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00281580     History of Changes
Other Study ID Numbers: 1235.1, 2008-000874-19
Study First Received: January 24, 2006
Results First Received: November 18, 2009
Last Updated: July 17, 2012
Health Authority: Argentina:
Brazil:
Mexico:
South Africa:
United States: Food and Drug Administration