Trial Outcomes & Findings for Telmisartan, Amlodipine and Combination in Healthy Subjects (NCT NCT01181011)

NCT ID: NCT01181011

Last Updated: 2014-07-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
• Results posted on: 2014-07-24

Participant Flow

Participant milestones

Measure	All Participants
Overall Study STARTED	28
Overall Study Received Telmisartan 80mg	27
Overall Study Received Telmisartan 80mg,Amlodipine 5mg	27
Overall Study Received Amlodipine 5mg	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	All Participants
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Telmisartan, Amlodipine and Combination in Healthy Subjects

Baseline characteristics by cohort

Measure	All Participants n=28 Participants all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
Age, Continuous	24 Years STANDARD_DEVIATION 2.0 • n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants

PRIMARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for AUC\_0-tz of Telmisartan

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 Participants	Telmisartan 80mg n=27 Participants	Amlodipine 5mg
Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)	3200 ng·h/mL Geometric Coefficient of Variation 74.7	2940 ng·h/mL Geometric Coefficient of Variation 94.4	—

PRIMARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for AUC\_0-∞ of Telmisartan

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 Participants	Telmisartan 80mg n=27 Participants	Amlodipine 5mg
Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan	3420 ng·h/mL Geometric Coefficient of Variation 82.5	3140 ng·h/mL Geometric Coefficient of Variation 98.5	—

PRIMARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for Cmax of Telmisartan

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 Participants	Telmisartan 80mg n=27 Participants	Amlodipine 5mg
The Maximum Observed Plasma Concentration (Cmax) of Telmisartan	461 ng/mL Geometric Coefficient of Variation 59.9	480 ng/mL Geometric Coefficient of Variation 78.3	—

PRIMARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for AUC\_0-tz of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
AUC_0-tz of Amlodipine	206 ng·h/mL Geometric Coefficient of Variation 28.6	192 ng·h/mL Geometric Coefficient of Variation 31	—

PRIMARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for AUC\_0-∞ of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
AUC_0-∞ of Amlodipine	225 ng·h/mL Geometric Coefficient of Variation 27.1	210 ng·h/mL Geometric Coefficient of Variation 30.9	—

PRIMARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs

Population: All patients with values for Cmax of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 Participants	Telmisartan 80mg n=26 Participants	Amlodipine 5mg
Cmax of Amlodipine	4.72 ng/mL Geometric Coefficient of Variation 21.7	4.43 ng/mL Geometric Coefficient of Variation 27.3	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for tmax of Telmisartan

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
Time to Attain Cmax (Tmax) of Telmisartan	1.22 h Standard Deviation 0.58 • Interval 0.5 to 3.0	1.16 h Standard Deviation 0.76 • Interval 0.5 to 4.02	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for λz of Telmisartan

reflect the speed of drug elimination in vivo

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
Terminal Rate Constant in Plasma (λz) of Telmisartan	0.0305 1/h Standard Deviation 0.0114	0.0323 1/h Standard Deviation 0.0124	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for MRT\_po of Telmisartan

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)	20.0 h Standard Deviation 4.8	18.4 h Standard Deviation 5.7	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for t\_½ of Telmisartan

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
Elimination Half-life (t_½) of Telmisartan	27.0 h Standard Deviation 13.7	25.0 h Standard Deviation 10.7	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for CL/F of Telmisartan

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)	31.0 L/h Standard Deviation 21.6	37.3 L/h Standard Deviation 39.7	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for V\_z/F of Telmisartan

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan	1021 L Standard Deviation 697	1135 L Standard Deviation 1018	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for tmax of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
Tmax of Amlodipine	6.88 h Standard Deviation 1.74 • Interval 6.0 to 12.0	7.20 h Standard Deviation 1.63 • Interval 6.0 to 12.0	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for λz of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
λz of Amlodipine	0.0305 1/h Standard Deviation 0.0114	0.0323 1/h Standard Deviation 0.0124	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for MRT\_po of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
MRT_po of Amlodipine	44.3 h Standard Deviation 7.0	43.7 h Standard Deviation 7.6	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for t\_½ of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
t_½ of Amlodipine	38.8 h Standard Deviation 7.6	38.6 h Standard Deviation 7.5	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for CL/F of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
CL/F of Amlodipine	22.7 L/h Standard Deviation 6.3	25.1 L/h Standard Deviation 7.9	—

SECONDARY outcome

Timeframe: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Population: All patients with values for V\_z/F of Amlodipine

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=25 Participants	Telmisartan 80mg n=25 Participants	Amlodipine 5mg
V_z/F of Amlodipine	1241 L Standard Deviation 313	1353 L Standard Deviation 369	—

SECONDARY outcome

Timeframe: 4 weeks

Population: Treated set

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 Participants	Telmisartan 80mg n=27 Participants	Amlodipine 5mg n=26 Participants
Number of Participants With at Least One Treatment Emergent Adverse Event	4 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Treated set

Outcome measures

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 Participants	Telmisartan 80mg n=27 Participants	Amlodipine 5mg n=26 Participants
Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities ECG abnormalities	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Vital signs abnormalities	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Physical finding abnormalities	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Laboratory finding abnormalities	1 Participants	1 Participants	0 Participants

Adverse Events

Telmisartan 80mg, Amlodipine 5mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Telmisartan 80mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Amlodipine 5mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Telmisartan 80mg, Amlodipine 5mg n=27 participants at risk	Telmisartan 80mg n=27 participants at risk	Amlodipine 5mg n=26 participants at risk
Infections and infestations Influenza	7.4% 2/27 • 4 weeks	3.7% 1/27 • 4 weeks	11.5% 3/26 • 4 weeks

Additional Information

Boehringer Ingelheim Pharmaceuticals

Boehringer Ingelheim Pharmaceuticals

Phone: 800-542-6257

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