Trial Outcomes & Findings for Open Label Study Telmisartan and Amlodipine in Hypertension (NCT NCT00614380)
NCT ID: NCT00614380
Last Updated: 2014-02-13
Results Overview
The number of patients who reach the target DBP of \<90mmHg
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
976 participants
Primary outcome timeframe
End of study (34 weeks or last value on treatment)
Results posted on
2014-02-13
Participant Flow
Participant milestones
| Measure |
Telmisartan 40mg and Amlodipine 5mg
|
Telmisartan 80mg and Amlodipine 5mg
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
564
|
206
|
25
|
181
|
|
Overall Study
COMPLETED
|
529
|
198
|
24
|
179
|
|
Overall Study
NOT COMPLETED
|
35
|
8
|
1
|
2
|
Reasons for withdrawal
| Measure |
Telmisartan 40mg and Amlodipine 5mg
|
Telmisartan 80mg and Amlodipine 5mg
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
14
|
4
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
0
|
0
|
|
Overall Study
Non compliant with the protocol
|
12
|
2
|
1
|
2
|
|
Overall Study
Consent withdrawn
|
3
|
1
|
0
|
0
|
Baseline Characteristics
Open Label Study Telmisartan and Amlodipine in Hypertension
Baseline characteristics by cohort
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=564 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=206 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=25 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=181 Participants
|
Total
n=976 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.8 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
52.9 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
54.4 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
53.9 Years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
240 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
365 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
324 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
611 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: 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
The number of patients who reach the target DBP of \<90mmHg
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=553 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=206 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=25 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=181 Participants
|
|---|---|---|---|---|
|
Trough Seated Diastolic Blood Pressure (DBP) Control
Yes (DBP<90 mmHg)
|
504 Participants
|
160 Participants
|
19 Participants
|
84 Participants
|
|
Trough Seated Diastolic Blood Pressure (DBP) Control
No (DBP>=90 mmHg)
|
49 Participants
|
46 Participants
|
6 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: 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
The number of patients who reach the target SBP of \<140mmHg
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=553 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=206 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=25 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=181 Participants
|
|---|---|---|---|---|
|
Trough Seated Systolic Blood Pressure (SBP) Control
Yes (SBP<140 mmHg)
|
440 Participants
|
142 Participants
|
16 Participants
|
89 Participants
|
|
Trough Seated Systolic Blood Pressure (SBP) Control
No (SBP>=140 mmHg)
|
113 Participants
|
64 Participants
|
9 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 1235.5) and at least one on treatment BP measurement 20-30 hours post dose
Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=549 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=203 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=24 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=176 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Trough Seated Diastolic Blood Pressure
|
-14.18 mmHg
Standard Error 0.31
|
-12.64 mmHg
Standard Error 0.52
|
-9.47 mmHg
Standard Error 1.51
|
-10.17 mmHg
Standard Error 0.56
|
SECONDARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement
The difference between the last available troughs represents the additional reduction in DBP in this study
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=545 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=203 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=24 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=180 Participants
|
|---|---|---|---|---|
|
Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
|
-3.54 mmHg
Standard Error 0.33
|
-5.52 mmHg
Standard Error 0.55
|
-5.51 mmHg
Standard Error 1.59
|
-5.74 mmHg
Standard Error 0.58
|
SECONDARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement
Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=549 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=203 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=24 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=176 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure
|
-17.79 mmHg
Standard Error 0.52
|
-15.91 mmHg
Standard Error 0.86
|
-12.6 mmHg
Standard Error 2.5
|
-14.04 mmHg
Standard Error 0.92
|
SECONDARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: All patients who took at least one dose of study medication, have a trough baseline measurement (Last value on treatment in 1235.5) and at least one on treatment BP measurement 20-30 hours post dose
The difference between the last available troughs represents the additional reduction in SBP in this study
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=545 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=203 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=24 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=180 Participants
|
|---|---|---|---|---|
|
Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
|
-4.14 mmHg
Standard Error 0.5
|
-5.62 mmHg
Standard Error 0.83
|
-3.6 mmHg
Standard Error 2.41
|
-7.17 mmHg
Standard Error 0.88
|
SECONDARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: 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
The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=553 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=206 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=25 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=181 Participants
|
|---|---|---|---|---|
|
Trough Seated DBP Response
Yes (Responder)
|
504 Participants
|
171 Participants
|
19 Participants
|
108 Participants
|
|
Trough Seated DBP Response
No (Non-responder)
|
45 Participants
|
32 Participants
|
5 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: 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
The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=553 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=206 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=25 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=181 Participants
|
|---|---|---|---|---|
|
Trough Seated SBP Response
No (Non-responder)
|
59 Participants
|
24 Participants
|
6 Participants
|
48 Participants
|
|
Trough Seated SBP Response
Yes (Responder)
|
490 Participants
|
179 Participants
|
18 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: End of study (34 weeks or last value on treatment)Population: 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
The number of patients who reach predefined BP categories
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=553 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=206 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=25 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
n=181 Participants
|
|---|---|---|---|---|
|
Trough Blood Pressure (BP) Normality Classes
Optimal (SBP<120 and DBP<80 mmHg)
|
67 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
|
Trough Blood Pressure (BP) Normality Classes
Normal (SBP<130 and DBP<85 mmHg and not optimal)
|
188 Participants
|
29 Participants
|
3 Participants
|
12 Participants
|
|
Trough Blood Pressure (BP) Normality Classes
High-normal (SBP<140 DBP<90 mmHg and not normal)
|
163 Participants
|
92 Participants
|
9 Participants
|
34 Participants
|
|
Trough Blood Pressure (BP) Normality Classes
Stage 1 hypertension (SBP<160 and DBP<100 mmHg
|
122 Participants
|
73 Participants
|
12 Participants
|
105 Participants
|
|
Trough Blood Pressure (BP) Normality Classes
Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg)
|
13 Participants
|
8 Participants
|
0 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: At any point during open-label treatmentPopulation: Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as 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
Time from first intake of medication to first intake of an antihypertensive other than the study drug
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=218 Participants
|
Telmisartan 80mg and Amlodipine 5mg
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
|
|---|---|---|---|---|
|
Time to First Additional Antihypertensive
|
85.8 Days
Standard Deviation 38.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At any point during open-label treatmentPopulation: Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as 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
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
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=12 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=206 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=218 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
|
|---|---|---|---|---|
|
Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Post-antihypertensive: Yes (DBP<90 mmHg)
|
10 Participants
|
100 Participants
|
110 Participants
|
—
|
|
Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Post-antihypertensive: No (DBP>=90 mmHg)
|
2 Participants
|
106 Participants
|
108 Participants
|
—
|
|
Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Post-antihypertensive: Total
|
12 Participants
|
206 Participants
|
218 Participants
|
—
|
SECONDARY outcome
Timeframe: At any point during open-label treatmentPopulation: Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as 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
Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=218 Participants
|
Telmisartan 80mg and Amlodipine 5mg
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
|
|---|---|---|---|---|
|
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
|
-5.73 mmHg
Standard Deviation 7.65
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At any point during open-label treatmentPopulation: Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as 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
Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=218 Participants
|
Telmisartan 80mg and Amlodipine 5mg
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
|
|---|---|---|---|---|
|
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
|
-7.53 mmHg
Standard Deviation 11.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At any point during open-label treatmentPopulation: Patients from the full analysis set who up-titrated to the higher dose of telmisartan 80 mg and amlodipine 10 mg. Full analysis set defined as 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
The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration
Outcome measures
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=17 Participants
|
Telmisartan 80mg and Amlodipine 5mg
n=361 Participants
|
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
n=378 Participants
|
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
|
|---|---|---|---|---|
|
Trough DBP Control Pre- and Post- Uptitration
Post-titration: Yes (DBP<90 mmHg)
|
17 Participants
|
190 Participants
|
207 Participants
|
—
|
|
Trough DBP Control Pre- and Post- Uptitration
Post-titration: No (DBP>=90 mmHg)
|
0 Participants
|
171 Participants
|
171 Participants
|
—
|
|
Trough DBP Control Pre- and Post- Uptitration
Post-titration: Total
|
17 Participants
|
361 Participants
|
378 Participants
|
—
|
Adverse Events
Telmisartan 40mg and Amlodipine 5mg
Serious events: 22 serious events
Other events: 57 other events
Deaths: 0 deaths
Telmisartan 80mg and Amlodipine 5mg
Serious events: 6 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=976 participants at risk
|
Telmisartan 80mg and Amlodipine 5mg
n=397 participants at risk
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Cardiac disorders
Atrial fibrillation
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Cardiac disorders
Cronary artery disease
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Congenital, familial and genetic disorders
Cystic lymphangioma
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Infections and infestations
Anal abscess
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Infections and infestations
Typhoid fever
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Investigations
Prostatic specific antigen increased
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Musculoskeletal and connective tissue disorders
Muscular disorder
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Nervous system disorders
Dizziness
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Psychiatric disorders
Depression
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Renal and urinary disorders
Renal colic
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.25%
1/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Vascular disorders
Perpheral artery aneurysm
|
0.10%
1/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
0.00%
0/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
Other adverse events
| Measure |
Telmisartan 40mg and Amlodipine 5mg
n=976 participants at risk
|
Telmisartan 80mg and Amlodipine 5mg
n=397 participants at risk
|
|---|---|---|
|
General disorders
Oedema peripheral
|
3.3%
32/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
5.3%
21/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
25/976 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
6.0%
24/397 • From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
|
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