Trial Outcomes & Findings for TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch (NCT NCT01134393)
NCT ID: NCT01134393
Last Updated: 2014-01-15
Results Overview
Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
502 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-01-15
Participant Flow
This was a prospective, single-arm, open-label, uncontrolled, multi-centre, international trial. Whilst 542 patients were enrolled, 502 entered the study. Since one patient refused to take study medication, only 501 patients were treated. The Full analysis set (FAS) consisted of 494 patients and this is the basis of most data presentations.
Participant milestones
| Measure |
T80/A5
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Overall Study
STARTED
|
501
|
|
Overall Study
COMPLETED
|
449
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
T80/A5
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Protocol Violation
|
12
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Other
|
6
|
Baseline Characteristics
TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch
Baseline characteristics by cohort
| Measure |
T80/A5
n=494 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
207 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
287 Participants
n=5 Participants
|
|
Systolic Blood Pressure (SBP) at time of baseline
|
151.4 mmHg
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Diastolic Blood Pressure (DBP) at time of baseline
|
91.8 mmHg
STANDARD_DEVIATION 8.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used.
Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.
Outcome measures
| Measure |
T80/A5
n=494 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.
|
67.6 Percentage of participants
Interval 63.3 to 71.7
|
SECONDARY outcome
Timeframe: 4 and 8 weeksPopulation: FAS and LOCF
Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.
Outcome measures
| Measure |
T80/A5
n=494 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.
Week 4
|
262 Number of participants
|
|
BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.
Week 8
|
330 Number of participants
|
SECONDARY outcome
Timeframe: Week 12Population: FAS and LOCF and with at least one post baseline HBPM measurement
Achieving BP control with HBPM is defined as SBP\<135 mmHg and DBP\<85 mmHg.
Outcome measures
| Measure |
T80/A5
n=409 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).
Morning
|
179 Number of participants
|
|
BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).
Evening
|
172 Number of participants
|
SECONDARY outcome
Timeframe: weeks 4, 8 and 12Population: FAS with non-missing data
Outcome measures
| Measure |
T80/A5
n=494 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Change at week 4 SBP (N=485)
|
-13.58 mmHg
Standard Deviation 11.95
|
|
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Change at week 8 SBP (N=487)
|
-16.37 mmHg
Standard Deviation 12.34
|
|
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Change at week 12 SBP (N=487)
|
-16.92 mmHg
Standard Deviation 12.24
|
|
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Change at week 4 DBP (N=485)
|
-8.24 mmHg
Standard Deviation 8.77
|
|
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Change at week 8 DBP (N=487)
|
-10.33 mmHg
Standard Deviation 8.88
|
|
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Change at week 12 DBP (N=487)
|
-10.43 mmHg
Standard Deviation 8.83
|
SECONDARY outcome
Timeframe: weeks 4, 8 and 12Population: Treated Set (TS) with non-missing data
Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.
Outcome measures
| Measure |
T80/A5
n=501 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate
Change at week 4 (N=482)
|
1.43 bpm
Standard Deviation 9.22
|
|
Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate
Change at week 8 (N=463)
|
0.32 bpm
Standard Deviation 9.21
|
|
Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate
Change at week 12 (N=344)
|
0.51 bpm
Standard Deviation 9.25
|
SECONDARY outcome
Timeframe: weeks 4, 8 and 12Population: There was no information in the Case Report Form (CRF)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: weeks 4, 8 and 12Population: FAS and LOCF
DBP control is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP \<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=10mmHg. SBP response is defined as SBP\<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=15mmHg.
Outcome measures
| Measure |
T80/A5
n=494 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 12 DBP control
|
373 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 4 DBP control
|
313 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 8 DBP control
|
368 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 4 SBP control
|
247 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 8 SBP control
|
305 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 12 SBP control
|
311 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 4 DBP response
|
329 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 8 DBP response
|
393 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 12 DBP response
|
399 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 4 SBP response
|
337 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 8 SBP response
|
388 Number of participants
|
|
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
Week 12 SBP response
|
393 Number of participants
|
SECONDARY outcome
Timeframe: weeks 4, 8 and 12Population: FAS with non-missing data
BP optimal: SBP \<120 mmHg and DBP \<80 mmHg, BP normal: SBP \<130 mmHg and DBP \<85 mmHg but not optimal, BP high-normal: SBP \<140 mmHg and DBP \<90 mmHg but not normal. Grade 1 hypertension: SBP \<160 mmHg and DBP \<100 mmHg but not high-normal, Grade 2 hypertension: SBP \<180 mmHg and DBP \<110 mmHg but not grade 1, Grade 3 hypertension: SBP \>=180 mmHg or DBP \>=110 mmHg.
Outcome measures
| Measure |
T80/A5
n=494 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP optimal at week 4 (N=482)
|
4.1 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP normal at week 4 (N=482)
|
19.7 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP high-normal at week 4 (N=482)
|
30.5 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 1 hypertension at week 4 (N=482)
|
39.0 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 2 hypertension at week 4 (N=482)
|
6.2 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 3 hypertension at week 4 (N=482)
|
0.4 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP optimal at week 8 (N=487)
|
5.5 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP normal at week 8 (N=487)
|
22.2 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP high-normal at week 8 (N=487)
|
40.0 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 1 hypertension at week 8 (N=487)
|
27.7 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 2 hypertension at week 8 (N=487)
|
4.3 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 3 hypertension at week 8 (N=487)
|
0.2 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP optimal at week 12 (N=487)
|
4.5 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP normal at week 12 (N=487)
|
28.5 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
BP high-normal at week 12 (N=487)
|
35.5 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 1 hypertension at week 12 (N=487)
|
27.1 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 2 hypertension at week 12 (N=487)
|
4.1 Percentage of participants
|
|
Percentage of Patients in Blood Pressure Categories Over Time
Grade 3 hypertension at week 12 (N=487)
|
0.2 Percentage of participants
|
SECONDARY outcome
Timeframe: weeks 4, 8 and 12Population: FAS and LOCF and with at least one post baseline HBPM measurement
DBP control: DBP \<85 mmHg, SBP control: SBP \<135 mmHg, DBP response: DBP \<85 mmHg or a reduction from baseline \>=10 mmHg, SBP response: SBP \<135 mmHg or a reduction from baseline \>= 15 mmHg
Outcome measures
| Measure |
T80/A5
n=409 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP response evening at week 4 (N=299)
|
204 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP response evening at week 8 (N=299)
|
183 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP response evening at week 12 (N=299)
|
190 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP control morning at week 4
|
256 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP control morning at week 8
|
242 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP control morning at week 12
|
252 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP control evening at week 4
|
272 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP control evening at week 8
|
247 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP control evening at week 12
|
263 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP control morning at week 4
|
204 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP control morning at week 8
|
198 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP control morning at week 12
|
206 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP control evening at week 4
|
204 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP control evening at week 8
|
183 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP control evening at week 12
|
190 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP response morning at week 4 (N=354)
|
256 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP response morning at week 8 (N=354)
|
242 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP response morning at week 12 (N=354)
|
252 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP response evening at week 4 (N=354)
|
272 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP response evening at week 8 (N=354)
|
247 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP response evening at week 12 (N=354)
|
263 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP response morning at week 4 (N=299)
|
204 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP response morning at week 8 (N=299)
|
198 Number of participants
|
|
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
SBP response morning at week 12 (N=299)
|
206 Number of participants
|
SECONDARY outcome
Timeframe: weeks 4 and 8Population: FAS
Outcome measures
| Measure |
T80/A5
n=501 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time
Week 4 (n=482)
|
186 Number of participants
|
|
Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time
Week 8 (n=284)
|
46 Number of participants
|
Adverse Events
T80/A5
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
T80/A10
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T80/A5
n=501 participants at risk
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
T80/A10
n=232 participants at risk
Telmisartan 80 mg plus Amlodipine 10 mg once daily
|
|---|---|---|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.20%
1/501 • 12 weeks: From drug administration until end of treatment plus one day.
|
0.00%
0/232 • 12 weeks: From drug administration until end of treatment plus one day.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/501 • 12 weeks: From drug administration until end of treatment plus one day.
|
0.43%
1/232 • 12 weeks: From drug administration until end of treatment plus one day.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/501 • 12 weeks: From drug administration until end of treatment plus one day.
|
0.43%
1/232 • 12 weeks: From drug administration until end of treatment plus one day.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/501 • 12 weeks: From drug administration until end of treatment plus one day.
|
0.43%
1/232 • 12 weeks: From drug administration until end of treatment plus one day.
|
Other adverse events
| Measure |
T80/A5
n=501 participants at risk
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
T80/A10
n=232 participants at risk
Telmisartan 80 mg plus Amlodipine 10 mg once daily
|
|---|---|---|
|
General disorders
Oedema peripheral
|
5.2%
26/501 • 12 weeks: From drug administration until end of treatment plus one day.
|
17.7%
41/232 • 12 weeks: From drug administration until end of treatment plus one day.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER