Trial Outcomes & Findings for Add-on to Micamlo BP Trial (NCT NCT01975246)

Results Overview

Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

309 participants

Primary outcome timeframe

baseline and week 8

Results posted on

2016-11-29

Participant Flow

This study is randomised, double-blind, active-control, parallel-group comparison

Participant milestones

Participant milestones
Measure	Telmisartan and Amlodipine+HCTZ Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.	Telmisartan+Amlodipine Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Overall Study STARTED	149	160
Overall Study COMPLETED	145	158
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Telmisartan and Amlodipine+HCTZ Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.	Telmisartan+Amlodipine Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Overall Study Adverse Event	2	1
Overall Study Lack of Efficacy	1	0
Overall Study Protocol Violation	1	0
Overall Study Other than stated	0	1

Baseline Characteristics

Add-on to Micamlo BP Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telmisartan and Amlodipine+HCTZ n=149 Participants Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.	Telmisartan+Amlodipine n=160 Participants Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet	Total n=309 Participants Total of all reporting groups
Age, Continuous	54.4 Years STANDARD_DEVIATION 9.1 • n=5 Participants	55.0 Years STANDARD_DEVIATION 9.7 • n=7 Participants	54.7 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	30 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	130 Participants n=7 Participants	257 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and week 8

Population: Full analysis set (FAS): This analysis set was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period.

Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.

Outcome measures

Outcome measures
Measure	Telmisartan and Amlodipine+HCTZ n=147 Participants Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.	Telmisartan+Amlodipine n=160 Participants Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.	-8.4 mmHg Standard Error 0.5	-4.5 mmHg Standard Error 0.5

SECONDARY outcome

Timeframe: baseline and week 8

Population: FAS

Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.

Outcome measures

Outcome measures
Measure	Telmisartan and Amlodipine+HCTZ n=147 Participants Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.	Telmisartan+Amlodipine n=160 Participants Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.	-12.3 mmHg Standard Error 0.8	-6.9 mmHg Standard Error 0.8

SECONDARY outcome

Timeframe: baseline and week 8

Population: FAS

Patients with trough seated DBP =\>90 mmHg or trough seated SBP \>=140 mmHg at baseline were analysed.

Outcome measures

Outcome measures
Measure	Telmisartan and Amlodipine+HCTZ n=147 Participants Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.	Telmisartan+Amlodipine n=160 Participants Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period	51.7 percentage of participants Interval 43.3 to 60.0	36.9 percentage of participants Interval 29.4 to 44.9

Adverse Events

Telmisartan and Amlodipine+HCTZ

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Telmisartan+Amlodipine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Telmisartan and Amlodipine+HCTZ n=149 participants at risk Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.	Telmisartan+Amlodipine n=160 participants at risk Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Infections and infestations Nasopharyngitis	6.0% 9/149 • From first drug administration until 24 hours after the last drug administration, up to 71 days.	5.6% 9/160 • From first drug administration until 24 hours after the last drug administration, up to 71 days.
Investigations Blood uric acid increased	13.4% 20/149 • From first drug administration until 24 hours after the last drug administration, up to 71 days.	3.1% 5/160 • From first drug administration until 24 hours after the last drug administration, up to 71 days.
Metabolism and nutrition disorders Hyperuricaemia	5.4% 8/149 • From first drug administration until 24 hours after the last drug administration, up to 71 days.	0.62% 1/160 • From first drug administration until 24 hours after the last drug administration, up to 71 days.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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