Trial Outcomes & Findings for Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus (NCT NCT00877929)
NCT ID: NCT00877929
Last Updated: 2014-03-12
Results Overview
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
706 participants
Primary outcome timeframe
Baseline, week 8
Results posted on
2014-03-12
Participant Flow
Participant milestones
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
352
|
354
|
|
Overall Study
COMPLETED
|
332
|
319
|
|
Overall Study
NOT COMPLETED
|
20
|
35
|
Reasons for withdrawal
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
20
|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Other reason (not specified)
|
2
|
6
|
Baseline Characteristics
Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=352 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=354 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Total
n=706 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Age, Customized
< 65 years
|
214 participants
n=5 Participants
|
235 participants
n=7 Participants
|
449 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
138 participants
n=5 Participants
|
119 participants
n=7 Participants
|
257 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 participants
n=5 Participants
|
40 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
43 participants
n=5 Participants
|
41 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Pacific Islander
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
270 participants
n=5 Participants
|
268 participants
n=7 Participants
|
538 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
27 participants
n=5 Participants
|
29 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
44 participants
n=5 Participants
|
42 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
33 participants
n=5 Participants
|
31 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Republic of Korea
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
36 participants
n=5 Participants
|
40 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
121 participants
n=7 Participants
|
241 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
53 participants
n=5 Participants
|
52 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Race class
Non-black
|
309 participants
n=5 Participants
|
313 participants
n=7 Participants
|
622 participants
n=5 Participants
|
|
Race class
Black
|
43 participants
n=5 Participants
|
41 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Height
|
167.1 centimeter
STANDARD_DEVIATION 10.3 • n=5 Participants
|
167.6 centimeter
STANDARD_DEVIATION 10.9 • n=7 Participants
|
167.4 centimeter
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Weight
|
90.2 kilogram
STANDARD_DEVIATION 20.9 • n=5 Participants
|
89.5 kilogram
STANDARD_DEVIATION 19.4 • n=7 Participants
|
89.9 kilogram
STANDARD_DEVIATION 20.2 • n=5 Participants
|
|
Body Mass Index
|
32.1 kilogram / square meter
STANDARD_DEVIATION 6.0 • n=5 Participants
|
31.8 kilogram / square meter
STANDARD_DEVIATION 6.1 • n=7 Participants
|
32.0 kilogram / square meter
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Body Mass Index Class
< 25 kg/square meter
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Body Mass Index Class
25 to <30 kg/square meter
|
114 participants
n=5 Participants
|
123 participants
n=7 Participants
|
237 participants
n=5 Participants
|
|
Body Mass Index Class
>= 30 kg/square meter
|
206 participants
n=5 Participants
|
200 participants
n=7 Participants
|
406 participants
n=5 Participants
|
|
Smoking history
Never smoked
|
221 participants
n=5 Participants
|
222 participants
n=7 Participants
|
443 participants
n=5 Participants
|
|
Smoking history
Ex-smoker
|
91 participants
n=5 Participants
|
89 participants
n=7 Participants
|
180 participants
n=5 Participants
|
|
Smoking history
Currently smokes
|
40 participants
n=5 Participants
|
43 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Alcohol history
Non drinker
|
227 participants
n=5 Participants
|
218 participants
n=7 Participants
|
445 participants
n=5 Participants
|
|
Alcohol history
Drinks - no interference
|
125 participants
n=5 Participants
|
136 participants
n=7 Participants
|
261 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 8Population: Treated Set includes all randomized participants who took at least one dose of treatment
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=320 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=311 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
|
-29.0 mmHg
Standard Error 0.66
|
-22.9 mmHg
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline, week 6Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=326 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=317 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6
|
-29.7 mmHg
Standard Error 0.62
|
-22.6 mmHg
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Baseline, week 4Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=329 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=326 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4
|
-27.7 mmHg
Standard Error 0.62
|
-21.1 mmHg
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline, week 2Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=333 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=332 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2
|
-22.4 mmHg
Standard Error 0.65
|
-16.4 mmHg
Standard Error 0.65
|
SECONDARY outcome
Timeframe: Baseline, week 1Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=336 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1
|
-17.5 mmHg
Standard Error 0.61
|
-12.6 mmHg
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Treated set using last observation carried forward (LOCF)
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=329 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks
|
237 participants
|
177 participants
|
SECONDARY outcome
Timeframe: Baseline, week 6Population: Treated set using LOCF
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=328 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks
|
245 participants
|
168 participants
|
SECONDARY outcome
Timeframe: Baseline, week 4Population: Treated set using LOCF
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=329 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=326 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks
|
235 participants
|
155 participants
|
SECONDARY outcome
Timeframe: Baseline, week 2Population: Treated set using LOCF
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=337 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=341 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks
|
184 participants
|
103 participants
|
SECONDARY outcome
Timeframe: Baseline, week 1Population: Treated set using LOCF
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=336 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week
|
130 participants
|
72 participants
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Treated set using LOCF
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=329 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks
|
121 participants
|
59 participants
|
SECONDARY outcome
Timeframe: Baseline, week 6Population: Treated set using LOCF
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=328 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks
|
134 participants
|
60 participants
|
SECONDARY outcome
Timeframe: Baseline, week 4Population: Treated set using LOCF
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=329 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=326 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks
|
94 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Baseline, week 2Population: Treated set using LOCF
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=337 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=341 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks
|
58 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Baseline, week 1Population: Treated set using LOCF
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=336 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week
|
35 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Treated set using LOCF
Mean seated SBP \< 140 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=329 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Systolic Blood Pressure (SBP) Control 140 at Eight Weeks
|
243 participants
|
187 participants
|
SECONDARY outcome
Timeframe: Baseline, week 6Population: Treated set using LOCF
Mean seated SBP \< 140 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=328 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 140 at Six Weeks
|
251 participants
|
177 participants
|
SECONDARY outcome
Timeframe: Baseline, week 4Population: Treated set using LOCF
Mean seated SBP \< 140 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=329 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=326 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 140 at Four Weeks
|
243 participants
|
163 participants
|
SECONDARY outcome
Timeframe: Baseline, week 2Population: Treated set using LOCF
Mean seated SBP \< 140 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=337 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=341 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 140 at Two Weeks
|
193 participants
|
112 participants
|
SECONDARY outcome
Timeframe: Baseline, week 1Population: Treated set using LOCF
Mean seated SBP \< 140 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=336 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 140 at One Week
|
141 participants
|
81 participants
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Treated set using LOCF
Mean seated SBP \< 130 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=329 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 130 at Eight Weeks
|
157 participants
|
89 participants
|
SECONDARY outcome
Timeframe: Baseline, week 6Population: Treated set using LOCF
Mean seated SBP \< 130 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=328 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 130 at Six Weeks
|
164 participants
|
81 participants
|
SECONDARY outcome
Timeframe: Baseline, week 4Population: Treated set using LOCF
Mean seated SBP \< 130 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=329 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=326 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 130 at Four Weeks
|
137 participants
|
70 participants
|
SECONDARY outcome
Timeframe: Baseline, week 2Population: Treated set using LOCF
Mean seated SBP \< 130 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=337 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=341 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 130 at Two Weeks
|
92 participants
|
42 participants
|
SECONDARY outcome
Timeframe: Baseline, week 1Population: Treated set using LOCF
Mean seated SBP \< 130 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=336 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Control 130 at One Week
|
50 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Treated set using LOCF
SBP \< 140 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=329 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 140 at Eight Weeks
|
309 participants
|
288 participants
|
SECONDARY outcome
Timeframe: Baseline, week 6Population: Treated set using LOCF
SBP \<140 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=328 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 140 at Six Weeks
|
318 participants
|
286 participants
|
SECONDARY outcome
Timeframe: Baseline, week 4Population: Treated set using LOCF
SBP \<140 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=329 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=326 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 140 at Four Weeks
|
309 participants
|
274 participants
|
SECONDARY outcome
Timeframe: Baseline, week 2Population: Treated set using LOCF
SBP \<140 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=337 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=341 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 140 at Two Weeks
|
297 participants
|
246 participants
|
SECONDARY outcome
Timeframe: Baseline, week 1Population: Treated set using LOCF
SBP \<140 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=336 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 140 at One Week
|
253 participants
|
201 participants
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Treated set using LOCF
SBP \<130 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=329 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 130 at Eight Weeks
|
309 participants
|
288 participants
|
SECONDARY outcome
Timeframe: Baseline, week 6Population: Treated set using LOCF
SBP \<130 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=328 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 130 at Six Weeks
|
318 participants
|
286 participants
|
SECONDARY outcome
Timeframe: Baseline, week 4Population: Treated set using LOCF
SBP \<130 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=329 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=326 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 130 at Four Weeks
|
309 participants
|
274 participants
|
SECONDARY outcome
Timeframe: Baseline, week 2Population: Treated set using LOCF
SBP \<130 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=337 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=341 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 130 at Two Weeks
|
297 participants
|
246 participants
|
SECONDARY outcome
Timeframe: Baseline, week 1Population: Treated set using LOCF
SBP \<130 mmHg or a reduction \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=336 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
SBP Response 130 at One Week
|
253 participants
|
199 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Treated set
Mean seated DBP\<80 mmHg or a reduction of \<=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=329 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
DBP Response at Eight Weeks
|
253 participants
|
214 participants
|
SECONDARY outcome
Timeframe: week 6Population: Treated set
Mean seated DBP\<80 mmHg or a reduction of \<=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=332 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=328 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
DBP Response at Six Weeks
|
275 participants
|
214 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Treated set
Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=329 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=326 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
DBP Response at Week Four
|
250 participants
|
190 participants
|
SECONDARY outcome
Timeframe: Week 2Population: Treated set
Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=337 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=341 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
DBP Response at Week Two
|
206 participants
|
166 participants
|
SECONDARY outcome
Timeframe: Week 1Population: Treated set
Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=336 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
DBP Response at Week One
|
165 participants
|
113 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Treated set
Change from baseline in UACR (measured in spot urine) after eight weeks of treatment
Outcome measures
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=334 Participants
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=333 Participants
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)
|
-0.36 ratio
Standard Deviation 0.79
|
0.04 ratio
Standard Deviation 0.92
|
Adverse Events
Telmisartan 80 mg + Amlodipine 10 mg
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
Amlodipine 10 mg
Serious events: 4 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=352 participants at risk
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=354 participants at risk
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/352
|
0.28%
1/354
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/352
|
0.28%
1/354
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/352
|
0.28%
1/354
|
|
General disorders
Ulcer
|
0.28%
1/352
|
0.00%
0/354
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/352
|
0.28%
1/354
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.28%
1/352
|
0.00%
0/354
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.28%
1/352
|
0.00%
0/354
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/352
|
0.28%
1/354
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/352
|
0.28%
1/354
|
|
Psychiatric disorders
Depression
|
0.00%
0/352
|
0.28%
1/354
|
|
Psychiatric disorders
Major depression
|
0.00%
0/352
|
0.28%
1/354
|
|
Vascular disorders
Arteriosclerosis
|
0.28%
1/352
|
0.00%
0/354
|
Other adverse events
| Measure |
Telmisartan 80 mg + Amlodipine 10 mg
n=352 participants at risk
Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
Amlodipine 10 mg
n=354 participants at risk
Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
17.6%
62/352
|
20.1%
71/354
|
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 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