Trial Outcomes & Findings for Telmisartan 80mg Non-responder Trial (NCT NCT01222520)

NCT ID: NCT01222520

Last Updated: 2014-06-27

Results Overview

Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, 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: 174 participants
• Primary outcome timeframe: Baseline, 8 weeks
• Results posted on: 2014-06-27

Participant Flow

Participant milestones

Measure	Telmisartan and Amlodipine FDC	Telmisartan
Open-label run-in Period STARTED	0	197
Open-label run-in Period COMPLETED	0	174
Open-label run-in Period NOT COMPLETED	0	23
Double-blind Period STARTED	87	87
Double-blind Period COMPLETED	86	85
Double-blind Period NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Telmisartan and Amlodipine FDC	Telmisartan
Open-label run-in Period Withdrawal by Subject	0	2
Open-label run-in Period Blood pressure criteria not met	0	18
Open-label run-in Period Number of patients fulfilled	0	3
Double-blind Period Adverse Event	0	1
Double-blind Period Lack of Efficacy	0	1
Double-blind Period Study medication stolen	1	0

Baseline Characteristics

Telmisartan 80mg Non-responder Trial

Baseline characteristics by cohort

Measure	Telmisartan and Amlodipine FDC n=87 Participants	Telmisartan n=87 Participants	Total n=174 Participants Total of all reporting groups
Age, Continuous	54.5 year STANDARD_DEVIATION 9.0 • n=5 Participants	54.8 year STANDARD_DEVIATION 8.6 • n=7 Participants	54.6 year STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	74 Participants n=7 Participants	141 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 weeks

Population: Full analysis set (FAS)

Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

Outcome measures

Measure	Telmisartan and Amlodipine FDC n=87 Participants	Telmisartan n=86 Participants
Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough	12.28 mmHg Standard Error 0.73	3.14 mmHg Standard Error 0.74

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: FAS

Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

Outcome measures

Measure	Telmisartan and Amlodipine FDC n=87 Participants	Telmisartan n=86 Participants
Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough	18.37 mmHg Standard Error 1.10	3.49 mmHg Standard Error 1.10

SECONDARY outcome

Timeframe: 8 weeks

Population: FAS

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

Measure	Telmisartan and Amlodipine FDC n=87 Participants	Telmisartan n=86 Participants
Seated DBP Control Rate at Trough No	29.9 Percentage of participants	73.3 Percentage of participants
Seated DBP Control Rate at Trough Yes	70.1 Percentage of participants	26.7 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 SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing

Outcome measures

Measure	Telmisartan and Amlodipine FDC n=50 Participants	Telmisartan n=52 Participants
Seated SBP Control Rate at Trough No	26.0 Percentage of participants	71.2 Percentage of participants
Seated SBP Control Rate at Trough Yes	74.0 Percentage of participants	28.8 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

Measure	Telmisartan and Amlodipine FDC n=87 Participants	Telmisartan n=86 Participants
Seated DBP Response Rate at Trough No	19.5 Percentage of participants	69.8 Percentage of participants
Seated DBP Response Rate at Trough Yes	80.5 Percentage of participants	30.2 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

Measure	Telmisartan and Amlodipine FDC n=87 Participants	Telmisartan n=86 Participants
Seated SBP Response Rate at Trough No	11.5 Percentage of participants	48.8 Percentage of participants
Seated SBP Response Rate at Trough Yes	88.5 Percentage of participants	51.2 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

Measure	Telmisartan and Amlodipine FDC n=87 Participants	Telmisartan n=86 Participants
Seated Blood Pressure (BP) Normalisation at Trough No	28 Participants	66 Participants
Seated Blood Pressure (BP) Normalisation at Trough Optimal	21 Participants	2 Participants
Seated Blood Pressure (BP) Normalisation at Trough Normal	22 Participants	7 Participants
Seated Blood Pressure (BP) Normalisation at Trough High-normal	16 Participants	11 Participants

Adverse Events

Telmisartan and Amlodipine FDC

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Telmisartan

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Telmisartan and Amlodipine FDC n=87 participants at risk	Telmisartan n=87 participants at risk
Infections and infestations Nasopharyngitis	5.7% 5/87 • From drug administration in the double blind treatment period until 24 hours after the last dosing, up to 63 days.	2.3% 2/87 • From drug administration in the double blind treatment period until 24 hours after the last dosing, up to 63 days.

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