Trial Outcomes & Findings for Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg) (NCT NCT01286558)

Last Updated: 2014-06-27

Results Overview

Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

225 participants

Primary outcome timeframe

Reference baseline, 8 weeks

Results posted on

2014-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Overall Study STARTED	112	113
Overall Study COMPLETED	111	111
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Overall Study Adverse Event	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=113 Participants	Total n=225 Participants Total of all reporting groups
Age, Continuous	54.6 year STANDARD_DEVIATION 8.4 • n=5 Participants	52.8 year STANDARD_DEVIATION 9.4 • n=7 Participants	53.7 year STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	89 Participants n=7 Participants	178 Participants n=5 Participants

PRIMARY outcome

Timeframe: Reference baseline, 8 weeks

Population: Full analysis set (FAS)

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants
Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough	4.93 mm Hg Standard Error 0.61	3.47 mm Hg Standard Error 0.61

SECONDARY outcome

Timeframe: Reference baseline, 8 weeks

Population: FAS

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants
Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough	5.55 mm Hg Standard Error 0.90	3.41 mm Hg Standard Error 0.91

SECONDARY outcome

Timeframe: Reference baseline, 8 weeks

Population: ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=105 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=107 Participants
Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP	-1.54 mm Hg Standard Error 0.49	-0.33 mm Hg Standard Error 0.49

SECONDARY outcome

Timeframe: Reference baseline, 8 weeks

Population: ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=105 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=107 Participants
Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP	-2.81 mm Hg Standard Error 0.81	-0.91 mm Hg Standard Error 0.82

SECONDARY outcome

Timeframe: Pseudo-baseline, 14 weeks

Population: ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=105 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=107 Participants
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP	-12.16 mm Hg Standard Error 0.61	-11.28 mm Hg Standard Error 0.60

SECONDARY outcome

Timeframe: Pseudo-baseline, 14 weeks

Population: ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=105 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=107 Participants
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP	-20.96 mm Hg Standard Error 0.96	-19.32 mm Hg Standard Error 0.95

SECONDARY outcome

Timeframe: Reference baseline, 8 weeks

Population: ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=105 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=107 Participants
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 9	-2.77 mm Hg Standard Deviation 12.83	-0.73 mm Hg Standard Deviation 12.44
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 16	-0.01 mm Hg Standard Deviation 10.73	0.85 mm Hg Standard Deviation 10.97
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 17	0.70 mm Hg Standard Deviation 12.16	-0.80 mm Hg Standard Deviation 11.07
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 18	-1.89 mm Hg Standard Deviation 11.81	1.02 mm Hg Standard Deviation 10.33
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 19	-3.12 mm Hg Standard Deviation 12.96	0.10 mm Hg Standard Deviation 10.38
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 20	0.23 mm Hg Standard Deviation 11.03	-1.27 mm Hg Standard Deviation 11.93
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 21	-3.25 mm Hg Standard Deviation 12.85	-0.90 mm Hg Standard Deviation 10.81
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 22	-2.00 mm Hg Standard Deviation 11.83	-1.67 mm Hg Standard Deviation 13.14
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 23	-2.07 mm Hg Standard Deviation 12.05	-0.53 mm Hg Standard Deviation 11.95
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 24	-0.82 mm Hg Standard Deviation 9.37	0.42 mm Hg Standard Deviation 11.23
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 1	-1.04 mm Hg Standard Deviation 10.27	-0.22 mm Hg Standard Deviation 12.38
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 2	-1.95 mm Hg Standard Deviation 11.44	0.32 mm Hg Standard Deviation 10.93
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 3	-2.25 mm Hg Standard Deviation 11.86	2.87 mm Hg Standard Deviation 11.61
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 4	-3.69 mm Hg Standard Deviation 12.43	-0.02 mm Hg Standard Deviation 10.63
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 5	-1.39 mm Hg Standard Deviation 13.22	-0.75 mm Hg Standard Deviation 14.06
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 6	-1.58 mm Hg Standard Deviation 11.08	-0.86 mm Hg Standard Deviation 13.32
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 7	-0.40 mm Hg Standard Deviation 12.24	-1.25 mm Hg Standard Deviation 13.22
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 8	-1.58 mm Hg Standard Deviation 13.23	0.55 mm Hg Standard Deviation 13.83
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 10	-2.80 mm Hg Standard Deviation 13.75	-0.14 mm Hg Standard Deviation 11.58
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 11	-1.47 mm Hg Standard Deviation 11.58	-1.16 mm Hg Standard Deviation 12.05
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 12	-0.74 mm Hg Standard Deviation 11.86	-1.43 mm Hg Standard Deviation 13.65
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 13	-2.33 mm Hg Standard Deviation 12.96	-1.05 mm Hg Standard Deviation 12.03
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 14	-0.53 mm Hg Standard Deviation 15.49	-0.08 mm Hg Standard Deviation 11.36
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 15	-0.36 mm Hg Standard Deviation 13.65	1.86 mm Hg Standard Deviation 10.88

SECONDARY outcome

Timeframe: Reference baseline, 8 weeks

Population: ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=105 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=107 Participants
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 1	-6.54 mm Hg Standard Deviation 16.03	-1.78 mm Hg Standard Deviation 16.37
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 6	-1.68 mm Hg Standard Deviation 18.39	-2.48 mm Hg Standard Deviation 20.01
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 11	-2.04 mm Hg Standard Deviation 19.59	0.69 mm Hg Standard Deviation 15.16
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 12	-4.57 mm Hg Standard Deviation 17.54	0.61 mm Hg Standard Deviation 16.89
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 2	-2.78 mm Hg Standard Deviation 14.98	-0.28 mm Hg Standard Deviation 15.82
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 3	-3.41 mm Hg Standard Deviation 16.83	2.72 mm Hg Standard Deviation 17.74
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 4	-4.72 mm Hg Standard Deviation 18.42	-1.88 mm Hg Standard Deviation 17.03
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 5	-1.14 mm Hg Standard Deviation 18.23	-2.54 mm Hg Standard Deviation 20.71
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 7	-0.60 mm Hg Standard Deviation 19.12	-2.45 mm Hg Standard Deviation 18.69
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 8	-2.05 mm Hg Standard Deviation 20.40	-0.27 mm Hg Standard Deviation 22.07
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 9	-3.09 mm Hg Standard Deviation 17.35	-1.17 mm Hg Standard Deviation 18.33
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 10	-5.78 mm Hg Standard Deviation 19.61	-0.70 mm Hg Standard Deviation 18.91
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 13	-2.27 mm Hg Standard Deviation 19.90	0.26 mm Hg Standard Deviation 17.53
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 14	-1.46 mm Hg Standard Deviation 21.12	-1.09 mm Hg Standard Deviation 17.49
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 15	-1.21 mm Hg Standard Deviation 17.86	1.41 mm Hg Standard Deviation 17.70
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 16	-0.78 mm Hg Standard Deviation 17.18	0.68 mm Hg Standard Deviation 15.42
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 17	-0.71 mm Hg Standard Deviation 17.58	-1.16 mm Hg Standard Deviation 15.67
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 18	-2.66 mm Hg Standard Deviation 18.90	1.01 mm Hg Standard Deviation 15.84
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 19	-4.58 mm Hg Standard Deviation 18.92	-1.24 mm Hg Standard Deviation 15.30
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 20	0.57 mm Hg Standard Deviation 19.07	-3.56 mm Hg Standard Deviation 17.02
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 21	-4.02 mm Hg Standard Deviation 17.27	-1.20 mm Hg Standard Deviation 16.47
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 22	-3.88 mm Hg Standard Deviation 16.81	-4.12 mm Hg Standard Deviation 17.40
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 23	-4.65 mm Hg Standard Deviation 21.01	-2.71 mm Hg Standard Deviation 16.15
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Hour 24	-2.24 mm Hg Standard Deviation 16.51	0.29 mm Hg Standard Deviation 16.09

SECONDARY outcome

Timeframe: 8 weeks

Population: Patients included in FAS and with seated DBP \>=90 mmHg at reference baseline

DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=49 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=50 Participants
Seated DBP Control Rate at Trough No	53.1 percentage of participants	60.0 percentage of participants
Seated DBP Control Rate at Trough Yes	46.9 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Patients included in FAS and with seated SBP \>=140 mmHg at reference baseline

SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=29 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=38 Participants
Seated SBP Control Rate at Trough No	55.2 percentage of participants	55.3 percentage of participants
Seated SBP Control Rate at Trough Yes	44.8 percentage of participants	44.7 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: FAS

DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (\<90 mmHg and/or reduction from reference baseline \>=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants
Seated DBP Response Rate at Trough No	29.5 percentage of participants	32.1 percentage of participants
Seated DBP Response Rate at Trough Yes	70.5 percentage of participants	67.9 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: FAS

SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (\<140 mmHg and/or reduction from reference baseline \>=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants
Seated SBP Response Rate at Trough No	19.6 percentage of participants	17.9 percentage of participants
Seated SBP Response Rate at Trough Yes	80.4 percentage of participants	82.1 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: FAS

Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing

Outcome measures

Outcome measures
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants	40 mg Telmisartan and 5 mg Amlodipine FDC n=112 Participants
Seated Blood Pressure (BP) Normalisation at Trough No	41 participants	44 participants
Seated Blood Pressure (BP) Normalisation at Trough Optimal	21 participants	13 participants
Seated Blood Pressure (BP) Normalisation at Trough Normal	23 participants	26 participants
Seated Blood Pressure (BP) Normalisation at Trough High-normal	27 participants	29 participants

Adverse Events

80 mg Telmisartan and 5 mg Amlodipine FDC

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

40 mg Telmisartan and 5 mg Amlodipine FDC

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=112 participants at risk	40 mg Telmisartan and 5 mg Amlodipine FDC n=113 participants at risk
Nervous system disorders Cerebral artery occlusion	0.89% 1/112 • From first drug administration in the double-blind treatment period until 24 hours after the last dose, up to 69 days	0.00% 0/113 • From first drug administration in the double-blind treatment period until 24 hours after the last dose, up to 69 days
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/112 • From first drug administration in the double-blind treatment period until 24 hours after the last dose, up to 69 days	0.88% 1/113 • From first drug administration in the double-blind treatment period until 24 hours after the last dose, up to 69 days

Other adverse events

Other adverse events
Measure	80 mg Telmisartan and 5 mg Amlodipine FDC n=112 participants at risk	40 mg Telmisartan and 5 mg Amlodipine FDC n=113 participants at risk
Infections and infestations Nasopharyngitis	5.4% 6/112 • From first drug administration in the double-blind treatment period until 24 hours after the last dose, up to 69 days	5.3% 6/113 • From first drug administration in the double-blind treatment period until 24 hours after the last dose, up to 69 days

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