Trial Outcomes & Findings for Telmisartan and Amlodipine Versus Monocomponent Tablets (NCT NCT01278797)
NCT ID: NCT01278797
Last Updated: 2014-03-28
Results Overview
Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Day 1, Day 22
Results posted on
2014-03-28
Participant Flow
Participant milestones
| Measure |
Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg
Combination tablet followed by individual components
|
Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg
Individual components followed by Combination tablet
|
|---|---|---|
|
Period 1
STARTED
|
14
|
14
|
|
Period 1
COMPLETED
|
13
|
13
|
|
Period 1
NOT COMPLETED
|
1
|
1
|
|
Washout Period of 21 Days
STARTED
|
13
|
13
|
|
Washout Period of 21 Days
COMPLETED
|
13
|
13
|
|
Washout Period of 21 Days
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
13
|
13
|
|
Period 2
COMPLETED
|
13
|
13
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg
Combination tablet followed by individual components
|
Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg
Individual components followed by Combination tablet
|
|---|---|---|
|
Period 1
Adverse Event
|
0
|
1
|
|
Period 1
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Telmisartan and Amlodipine Versus Monocomponent Tablets
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=28 Participants
Includes all subjects randomized to either treatment sequence
|
|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
|
Height
|
173.1 centimeter
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Weight
|
80.3 kilogram
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Body Mass Index
|
26.7 kilogram / square meter
STANDARD_DEVIATION 2.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 22Population: Analysis Set includes all randomized participants who completed the trial
Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method
Outcome measures
| Measure |
Telm/Amlo 80 mg/10 mg
n=26 Participants
Combination tablet
|
Telm 80 mg + Amlo 10 mg
n=26 Participants
Individual tablets
|
|---|---|---|
|
Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
|
260.7971 nanograms*hour/milliliter
Standard Deviation 60.8717
|
276.6315 nanograms*hour/milliliter
Standard Deviation 66.1935
|
PRIMARY outcome
Timeframe: Day 1, Day 22Population: Analysis Set includes all randomized participants who completed the trial
Outcome measures
| Measure |
Telm/Amlo 80 mg/10 mg
n=26 Participants
Combination tablet
|
Telm 80 mg + Amlo 10 mg
n=26 Participants
Individual tablets
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Amlodipine
|
6.7465 nanograms/milliliter
Standard Deviation 1.3354
|
7.2258 nanograms/milliliter
Standard Deviation 1.6549
|
SECONDARY outcome
Timeframe: Day 1, Day 22Population: Analysis Set includes all randomized participants who completed the trial
Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period
Outcome measures
| Measure |
Telm/Amlo 80 mg/10 mg
n=26 Participants
Combination tablet
|
Telm 80 mg + Amlo 10 mg
n=26 Participants
Individual tablets
|
|---|---|---|
|
Time of Maximum Concentration of Amlodipine (TMAX)
|
6.69 hours
Standard Deviation 1.95
|
6.12 hours
Standard Deviation 1.40
|
Adverse Events
Telm/Amlo 80 mg/10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Telm 80 mg + Amlo 10 mg
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 |
Telm/Amlo 80 mg/10 mg
n=27 participants at risk
Combination tablet
|
Telm 80 mg + Amlo 10 mg
n=27 participants at risk
Individual tablets
|
|---|---|---|
|
Renal and urinary disorders
Blood urine present
|
3.7%
1/27 • 30 Days
|
7.4%
2/27 • 30 Days
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • 30 Days
|
3.7%
1/27 • 30 Days
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/27 • 30 Days
|
7.4%
2/27 • 30 Days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - 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