Trial Outcomes & Findings for An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy (NCT NCT01103960)

NCT ID: NCT01103960

Last Updated: 2014-06-27

Results Overview

Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 324 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2014-06-27

Participant Flow

Whilst there were 324 patients randomised and treated, there were only 314 in the Full analysis set (FAS).

Participant milestones

Measure	A5 Alone Amlodipine 5mg monotherapy	T80/A5 Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Study STARTED	164	160
Overall Study COMPLETED	159	158
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Measure	A5 Alone Amlodipine 5mg monotherapy	T80/A5 Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	2	1
Overall Study Other	1	0

Baseline Characteristics

An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

Baseline characteristics by cohort

Measure	A5 Alone n=159 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination	Total n=314 Participants Total of all reporting groups
Age, Continuous	52.4 Years STANDARD_DEVIATION 9.7 • n=5 Participants	52.4 Years STANDARD_DEVIATION 8.7 • n=7 Participants	52.4 Years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	78 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	77 Participants n=7 Participants	165 Participants n=5 Participants
Diastolic blood pressure (DBP)	97.84 mmHg STANDARD_DEVIATION 6.43 • n=5 Participants	97.21 mmHg STANDARD_DEVIATION 5.46 • n=7 Participants	97.53 mmHg STANDARD_DEVIATION 5.97 • n=5 Participants
Systolic blood pressure (SBP)	146.27 mmHg STANDARD_DEVIATION 11.15 • n=5 Participants	146.44 mmHg STANDARD_DEVIATION 12.20 • n=7 Participants	146.35 mmHg STANDARD_DEVIATION 11.66 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.

Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.

Outcome measures

Measure	A5 Alone n=159 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Change From Baseline in DBP After 8 Weeks of Treatment	-10.19 mmHg Standard Error 0.93	-12.38 mmHg Standard Error 0.95

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: FAS with LOCF and further restricted to the Chinese subgroup

Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.

Outcome measures

Measure	A5 Alone n=133 Participants Amlodipine 5mg monotherapy	T80/A5 n=129 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients	-8.85 mmHg Standard Error 0.63	-10.77 mmHg Standard Error 0.64

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: FAS with LOCF

Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.

Outcome measures

Measure	A5 Alone n=159 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Change From Baseline in SBP After 8 Weeks of Treatment	-11.66 mmHg Standard Error 1.30	-16.15 mmHg Standard Error 1.33

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: FAS with LOCF

DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.

Outcome measures

Measure	A5 Alone n=159 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
DBP and SBP Control and Response After 8 Weeks of Treatment DBP control	85 Number of participants	112 Number of participants
DBP and SBP Control and Response After 8 Weeks of Treatment SBP control	100 Number of participants	119 Number of participants
DBP and SBP Control and Response After 8 Weeks of Treatment DBP response	101 Number of participants	124 Number of participants
DBP and SBP Control and Response After 8 Weeks of Treatment SBP response	120 Number of participants	131 Number of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: FAS with LOCF

BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.

Outcome measures

Measure	A5 Alone n=159 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Number of Patients in Blood Pressure Categories Over Time BP optimal	7 Number of participants	11 Number of participants
Number of Patients in Blood Pressure Categories Over Time BP normal	33 Number of participants	36 Number of participants
Number of Patients in Blood Pressure Categories Over Time BP high-normal	32 Number of participants	53 Number of participants
Number of Patients in Blood Pressure Categories Over Time Grade 1 hypertension	69 Number of participants	48 Number of participants
Number of Patients in Blood Pressure Categories Over Time Grade 2 hypertension	15 Number of participants	5 Number of participants
Number of Patients in Blood Pressure Categories Over Time Grade 3 hypertension	3 Number of participants	2 Number of participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: FAS with LOCF

Seated trough DBP after 4 weeks.

Outcome measures

Measure	A5 Alone n=158 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Change From Baseline in DBP After 4 Weeks of Treatment	-7.51 mmHg Standard Deviation 6.80	-9.41 mmHg Standard Deviation 7.26

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: FAS with LOCF

Seated trough SBP after 4 weeks.

Outcome measures

Measure	A5 Alone n=158 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Change From Baseline in SBP After 4 Weeks of Treatment	-8.19 mmHg Standard Deviation 11.45	-12.10 mmHg Standard Deviation 11.68

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: FAS with LOCF

DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.

Outcome measures

Measure	A5 Alone n=159 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
DBP and SBP Control and Response After 4 Weeks of Treatment DBP control	71 Number of participants	95 Number of participants
DBP and SBP Control and Response After 4 Weeks of Treatment SBP control	91 Number of participants	103 Number of participants
DBP and SBP Control and Response After 4 Weeks of Treatment DBP response	87 Number of participants	108 Number of participants
DBP and SBP Control and Response After 4 Weeks of Treatment SBP response	108 Number of participants	124 Number of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: FAS with LOCF

BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.

Outcome measures

Measure	A5 Alone n=159 Participants Amlodipine 5mg monotherapy	T80/A5 n=155 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Number of Patients in Blood Pressure Categories at 4 Weeks BP optimal	1 Number of participants	7 Number of participants
Number of Patients in Blood Pressure Categories at 4 Weeks BP normal	20 Number of participants	26 Number of participants
Number of Patients in Blood Pressure Categories at 4 Weeks BP high-normal	35 Number of participants	44 Number of participants
Number of Patients in Blood Pressure Categories at 4 Weeks Grade 1 hypertension	81 Number of participants	62 Number of participants
Number of Patients in Blood Pressure Categories at 4 Weeks Grade 2 hypertension	17 Number of participants	15 Number of participants
Number of Patients in Blood Pressure Categories at 4 Weeks Grade 3 hypertension	5 Number of participants	1 Number of participants

SECONDARY outcome

Timeframe: From drug administration until end of treatment plus one day

Population: Treated set included patients who were randomised and took at least one dose of the trial medication in the double-blind treatment period.

Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Outcome measures

Measure	A5 Alone n=164 Participants Amlodipine 5mg monotherapy	T80/A5 n=160 Participants Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Atrial fibrilation	0 participants	1 participants
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Myocardial ischaemia	1 participants	0 participants
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Blood glucose increased	1 participants	4 participants
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Protein urine present	2 participants	1 participants
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Alanine aminotransferase increased	0 participants	1 participants
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Blood creatinine phosphokinase increased	1 participants	0 participants
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Blood creatinine increased	0 participants	1 participants
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Blood glucose abnormal	1 participants	1 participants
Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. Heart rate increased	0 participants	1 participants

Adverse Events

A5 Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

T80/A5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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