Trial Outcomes & Findings for Filtered Trial for Telmisartan 40mg Non-responder (NCT NCT00550953)

NCT ID: NCT00550953

Last Updated: 2014-01-30

Results Overview

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 314 participants
• Primary outcome timeframe: Baseline and 8 Weeks
• Results posted on: 2014-01-30

Participant Flow

Participant milestones

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy A5 capsule, oral, once daily in the morning
Overall Study STARTED	156	158
Overall Study COMPLETED	150	152
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy A5 capsule, oral, once daily in the morning
Overall Study Adverse Event	4	3
Overall Study Not able to visit the site	2	3

Baseline Characteristics

Filtered Trial for Telmisartan 40mg Non-responder

Baseline characteristics by cohort

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=156 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 Participants A5 capsule, oral, once daily in the morning	Total n=314 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 9.1 • n=5 Participants	55.5 years STANDARD_DEVIATION 10.2 • n=7 Participants	55.5 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	35 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	123 Participants n=7 Participants	237 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 Weeks

Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

Outcome measures

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=153 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 Participants A5 capsule, oral, once daily in the morning
Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks	13.49 mmHg Standard Error 0.63	5.47 mmHg Standard Error 0.62

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.

The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

Outcome measures

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=153 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 Participants A5 capsule, oral, once daily in the morning
Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks	17.86 mmHg Standard Error 0.86	6.51 mmHg Standard Error 0.84

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.

Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake

Outcome measures

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=153 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 Participants A5 capsule, oral, once daily in the morning
Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)	78.4 percentage of participants	46.8 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.

Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake

Outcome measures

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=101 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=97 Participants A5 capsule, oral, once daily in the morning
Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)	81.2 percentage of participants	37.1 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.

Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks

Outcome measures

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=153 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 Participants A5 capsule, oral, once daily in the morning
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)	85 percentage of participants	50 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.

Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)

Outcome measures

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=153 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 Participants A5 capsule, oral, once daily in the morning
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)	89.5 percentage of participants	58.2 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.

Optimal, normal, high normal blood pressure were defined as follows:

• Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg
• Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg
• High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg

Outcome measures

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=153 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 Participants A5 capsule, oral, once daily in the morning
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) Optimal	17.0 percentage of participants	3.2 percentage of participants
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) Normal	30.7 percentage of participants	17.1 percentage of participants
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) High Normal	26.1 percentage of participants	17.1 percentage of participants

SECONDARY outcome

Timeframe: First administration of randomised treatment to 24 hours post last dose of randomised treatment

Population: Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or T40 during the double-blind treatment period.

Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Outcome measures

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=156 Participants T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 Participants A5 capsule, oral, once daily in the morning
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG Eosinophil count increased	1 participants	0 participants
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG Arrhythmia	1 participants	0 participants
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG Blood potassium increased	1 participants	0 participants
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG Blood pressure increased	0 participants	2 participants
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG Orthostatic hypotension	1 participants	0 participants

Adverse Events

Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Telmisartan 40 mg Monotherapy

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=156 participants at risk T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 participants at risk A5 capsule, oral, once daily in the morning
Injury, poisoning and procedural complications Forearm fracture	0.64% 1/156 • From drug administration until 24 hours after last drug administration	0.00% 0/158 • From drug administration until 24 hours after last drug administration

Other adverse events

Measure	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination n=156 participants at risk T40/A5 tablet, oral, once daily in the morning	Telmisartan 40 mg Monotherapy n=158 participants at risk A5 capsule, oral, once daily in the morning
Infections and infestations Nasopharyngitis	12.2% 19/156 • From drug administration until 24 hours after last drug administration	10.1% 16/158 • From drug administration until 24 hours after last drug administration

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