Trial Outcomes & Findings for 26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension (NCT NCT00624052)

NCT ID: NCT00624052

Last Updated: 2014-05-20

Results Overview

The number of patients who reached the target DBP of \<90mmHg

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 838 participants
• Primary outcome timeframe: End of study (34 weeks or last value on treatment)
• Results posted on: 2014-05-20

Participant Flow

Participant milestones

Measure	Telmisartan 40mg and Amlodipine 10mg Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit	Randomised Telmisartan 80mg and Amlodipine 10mg Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit	Titrated Telmisartan 80mg and Amlodipine 10mg Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit
Overall Study STARTED	219	436	91	92
Overall Study COMPLETED	204	422	88	88
Overall Study NOT COMPLETED	15	14	3	4

Reasons for withdrawal

Measure	Telmisartan 40mg and Amlodipine 10mg Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit	Randomised Telmisartan 80mg and Amlodipine 10mg Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit	Titrated Telmisartan 80mg and Amlodipine 10mg Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit
Overall Study Adverse Event	7	6	0	3
Overall Study Lack of Efficacy	1	1	0	0
Overall Study Lost to Follow-up	2	3	1	0
Overall Study Non compliant with the protocol	2	1	1	1
Overall Study Consent withdrawn	3	1	1	0
Overall Study Changed job/ran out if meds	0	2	0	0

Baseline Characteristics

26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

Baseline characteristics by cohort

Measure	Telmisartan 40mg and Amlodipine 10mg n=219 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=436 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=91 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=92 Participants	Total n=838 Participants Total of all reporting groups
Age, Continuous	56.2 Years STANDARD_DEVIATION 9.9 • n=5 Participants	57.3 Years STANDARD_DEVIATION 9.4 • n=7 Participants	55.2 Years STANDARD_DEVIATION 9.7 • n=5 Participants	53.3 Years STANDARD_DEVIATION 10.3 • n=4 Participants	56.4 Years STANDARD_DEVIATION 9.7 • n=21 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	206 Participants n=7 Participants	31 Participants n=5 Participants	37 Participants n=4 Participants	367 Participants n=21 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	230 Participants n=7 Participants	60 Participants n=5 Participants	55 Participants n=4 Participants	471 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 reached the target DBP of <90mmHg

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=216 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=436 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=91 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=92 Participants
Trough Seated Diastolic Blood Pressure (DBP) Control Yes (DBP<90 mmHg)	201 patients	402 patients	72 patients	70 patients
Trough Seated Diastolic Blood Pressure (DBP) Control No (DBP>=90 mmHg)	15 patients	34 patients	19 patients	22 patients

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 reached the target SBP of >=140mmHg

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=216 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=436 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=91 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=92 Participants
Trough Seated Systolic Blood Pressure (SBP) Control Yes (SBP<140 mmHg)	179 patients	366 patients	70 patients	51 patients
Trough Seated Systolic Blood Pressure (SBP) Control No (SBP>=140 mmHg)	37 patients	70 patients	21 patients	41 patients

SECONDARY outcome

Timeframe: Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 NCT00553267) 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 1235.6

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=214 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=434 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=87 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=91 Participants
Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure	-13.41 mmHg Standard Error 0.44	-13.36 mmHg Standard Error 0.31	-11.52 mmHg Standard Error 0.69	-10.64 mmHg Standard Error 0.67

SECONDARY outcome

Timeframe: Last available trough in NCT00553267 to 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 end of study measurement from NCT00553267 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 DBP in this study

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=213 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=430 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=91 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=92 Participants
Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052	-4.36 mmHg Standard Error 0.48	-4.97 mmHg Standard Error 0.34	-5.51 mmHg Standard Error 0.74	-5.43 mmHg Standard Error 0.73

SECONDARY outcome

Timeframe: Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose

Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=214 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=434 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=87 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=91 Participants
Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure	-14.76 mmHg Standard Error 0.72	-15.93 mmHg Standard Error 0.5	-14.85 mmHg Standard Error 1.12	-12.44 mmHg Standard Error 1.1

SECONDARY outcome

Timeframe: Last available trough in NCT00624052 to 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 end of study measurement from NCT00553267 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 10mg n=213 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=430 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=91 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=92 Participants
Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052	-4.73 mmHg Standard Error 0.73	-6.02 mmHg Standard Error 0.51	-6.55 mmHg Standard Error 1.11	-5.61 mmHg Standard Error 1.1

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 NCT 00553267) and 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 10mg n=214 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=434 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=87 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=91 Participants
Trough Seated DBP Response Yes (Responder)	201 patients	405 patients	71 patients	73 patients
Trough Seated DBP Response No (Non-responder)	13 patients	29 patients	16 patients	18 patients

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 NCT 00553267) and 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 10mg n=214 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=434 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=87 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=91 Participants
Trough Seated SBP Response Yes (Responder)	190 patients	401 patients	75 patients	69 patients
Trough Seated SBP Response No (Non-responder)	24 patients	33 patients	12 patients	22 patients

SECONDARY outcome

Timeframe: End of study (34 weeks or last value on treatment)

The number of patients who reach predefined BP categories

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=213 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=430 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=91 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on n=92 Participants
Trough BP Normality Classes Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg)	8 patients	5 patients	3 patients	4 patients
Trough BP Normality Classes Optimal (SBP<120 and DBP<80 mmHg)	12 patients	20 patients	5 patients	3 patients
Trough BP Normality Classes Normal (SBP<130 and DBP<85 mmHg and not optimal)	70 patients	146 patients	14 patients	13 patients
Trough BP Normality Classes High-normal (SBP<140 DBP<90 mmHg and not normal)	94 patients	189 patients	46 patients	29 patients
Trough BP Normality Classes Stage 1 hypertension (SBP<160 and DBP<100 mmHg	32 patients	76 patients	23 patients	43 patients

SECONDARY outcome

Timeframe: up to 34 weeks

Population: The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

Time from first intake of medication to first intake of an antihypertensive other than the study drug

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=121 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg	Titrated Telmisartan 80mg and Amlodipine 10mg	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Time to First Additional Antihypertensive	91.9 Days Standard Deviation 45.2	—	—	—

SECONDARY outcome

Timeframe: up to 34 weeks

Population: Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

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 10mg n=31 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=90 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=121 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control Post-antihypertensive: Yes (DBP<90 mmHg)	27 patients	67 patients	94 patients	—
Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control Post-antihypertensive: No (DBP>=90 mmHg)	4 patients	23 patients	27 patients	—
Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control Post-antihypertensive: Total	31 patients	90 patients	121 patients	—

SECONDARY outcome

Timeframe: up to 34 weeks

Population: Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=121 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg	Titrated Telmisartan 80mg and Amlodipine 10mg	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy	-6.79 mmHg Standard Deviation 7.39	—	—	—

SECONDARY outcome

Timeframe: up to 34 weeks

Population: Total for the full analysis set

Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=121 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg	Titrated Telmisartan 80mg and Amlodipine 10mg	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy	-7.79 mmHg Standard Deviation 12.37	—	—	—

SECONDARY outcome

Timeframe: up to 34 weeks

Population: 91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.

The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.

Outcome measures

Measure	Telmisartan 40mg and Amlodipine 10mg n=324 Participants	Randomised Telmisartan 80mg and Amlodipine 10mg n=258 Participants	Titrated Telmisartan 80mg and Amlodipine 10mg n=582 Participants	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Trough DBP Control Pre- and Post- Uptitration Post-titration: Yes (DBP<90 mmHg)	306 patients	168 patients	474 patients	—
Trough DBP Control Pre- and Post- Uptitration Post-titration: No (DBP>=90 mmHg)	18 patients	90 patients	108 patients	—
Trough DBP Control Pre- and Post- Uptitration Post-titration: Total	324 patients	258 patients	582 patients	—

Adverse Events

Telmisartan 40mg and Amlodipine 10mg

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Telmisartan 80mg and Amlodipine 10mg

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telmisartan 40mg and Amlodipine 10mg n=838 participants at risk The 838 participants in the telmisartan 40mg/amlodipine 10mg group includes all participants	Telmisartan 80mg and Amlodipine 10mg n=611 participants at risk The 611 participants in the telmisartan 80mg/amlodipine 10mg (T80/A10) group include 436 patients in the randomised T80/A10 group + 91 patients in the uptitrated T80/A10 group + XX patients in the T80/A10 + add-on group
Cardiac disorders Atrial fibrillation	0.12% 1/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Cardiac disorders Cardiac failure chronic	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Cardiac disorders Myocardial ischaemia	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
General disorders Chest pain	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Hepatobiliary disorders Cholecystitis	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Infections and infestations Pulmonary tuberculosis	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Infections and infestations Stent related infection	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Infections and infestations Vestibular neuronitis	0.12% 1/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.00% 0/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Injury, poisoning and procedural complications Fall	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Injury, poisoning and procedural complications Postoperative fever	0.12% 1/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.00% 0/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.12% 1/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.00% 0/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Renal and urinary disorders Calculus ureteric	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Reproductive system and breast disorders Benign prostatic hyperplasia	0.12% 1/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.00% 0/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.12% 1/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Skin and subcutaneous tissue disorders Parasoriasis	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Vascular disorders Aortic dissection	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.16% 1/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
Vascular disorders Hypertensive crisis	0.00% 0/838 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive	0.33% 2/611 • From day of first dose through to the day after last dose Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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