Trial Outcomes & Findings for Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine (NCT NCT01911780)
NCT ID: NCT01911780
Last Updated: 2016-03-28
Results Overview
Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
132 participants
Primary outcome timeframe
baseline and 8 weeks
Results posted on
2016-03-28
Participant Flow
Of the 239 enrolled patients, 205 patients were entered in the run-in period and 132 were randomized. The remaining 107 patients were withdrawn from the trial before the randomization.
An eight-week randomised, double-blind study with active-control and parallel-group comparison in Japanese patients plus 52 week extension period.
Participant milestones
| Measure |
Telmisartan + HCTZ + Amlodipine
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
|---|---|---|
|
Double-blind Period (8 Weeks)
STARTED
|
68
|
64
|
|
Double-blind Period (8 Weeks)
COMPLETED
|
65
|
61
|
|
Double-blind Period (8 Weeks)
NOT COMPLETED
|
3
|
3
|
|
Extension Period (52 Weeks)
STARTED
|
65
|
61
|
|
Extension Period (52 Weeks)
COMPLETED
|
61
|
58
|
|
Extension Period (52 Weeks)
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Telmisartan + HCTZ + Amlodipine
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
|---|---|---|
|
Double-blind Period (8 Weeks)
Adverse Event
|
1
|
2
|
|
Double-blind Period (8 Weeks)
Consent withdrawn not due to AEs
|
1
|
1
|
|
Double-blind Period (8 Weeks)
Personal reason
|
1
|
0
|
|
Extension Period (52 Weeks)
Adverse Event
|
3
|
0
|
|
Extension Period (52 Weeks)
Consent withdrawn not due to AEs
|
0
|
2
|
|
Extension Period (52 Weeks)
Personal reason
|
1
|
1
|
Baseline Characteristics
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
Baseline characteristics by cohort
| Measure |
Telmisartan + HCTZ + Amlodipine
n=68 Participants
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
n=64 Participants
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
54.4 Years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
55.2 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 8 weeksPopulation: Full analysis set (FAS) was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period
Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Outcome measures
| Measure |
Telmisartan + HCTZ + Amlodipine
n=67 Participants
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
n=64 Participants
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
|---|---|---|
|
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
|
-8.8 mmHg
Standard Error 0.8
|
-1.3 mmHg
Standard Error 0.8
|
SECONDARY outcome
Timeframe: baseline and 8 weeksPopulation: FAS
Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Outcome measures
| Measure |
Telmisartan + HCTZ + Amlodipine
n=67 Participants
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
n=64 Participants
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
|---|---|---|
|
Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
|
-10.6 mmHg
Standard Error 1.4
|
-2.1 mmHg
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Double-blind and 8 weeksPopulation: FAS
The percentage of patients with DBP\<90 mmHg and SBP\<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Outcome measures
| Measure |
Telmisartan + HCTZ + Amlodipine
n=67 Participants
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
n=64 Participants
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
|---|---|---|
|
The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.
|
44.8 Participants
Interval 32.6 to 57.4
|
21.9 Participants
Interval 12.5 to 34.0
|
SECONDARY outcome
Timeframe: Reference baseline (week 0) and week 60 (end of extension period)Population: FAS
The number of patients with DBP\<90 mmHg and SBP\<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Outcome measures
| Measure |
Telmisartan + HCTZ + Amlodipine
n=65 Participants
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
n=61 Participants
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
|---|---|---|
|
The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.
Yes
|
41 Participants
Interval 32.6 to 57.4
|
33 Participants
Interval 12.5 to 34.0
|
|
The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.
No
|
24 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Reference baseline (week 0) and week 60 (end of extension period)Population: FAS in the extension period (FASEX OC) was defined as a collection of patients i) included in the FAS; ii) taking at least 1 dose of T80/A5/H12.5 mg in the extension period; and iii) taking measurements of seated DBP at reference baseline and at 1 or more time points in the extension period.
Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Outcome measures
| Measure |
Telmisartan + HCTZ + Amlodipine
n=61 Participants
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
n=58 Participants
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
|---|---|---|
|
Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.
Mean
|
-11.4 mmHg
Standard Error 1.0
|
-10.0 mmHg
Standard Error 1.0
|
|
Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.
Adjusted mean
|
-10.9 mmHg
Standard Error 1.0
|
-10.5 mmHg
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Reference baseline (week 0) and week 60 (end of extension period)Population: FASEX (OC)
Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Outcome measures
| Measure |
Telmisartan + HCTZ + Amlodipine
n=61 Participants
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
Telmisartan + HCTZ + Placebo
n=58 Participants
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
|
|---|---|---|
|
Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.
Mean
|
-14.8 mmHg
Standard Error 1.6
|
-14.3 mmHg
Standard Error 1.6
|
|
Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.
Adjusted mean
|
-13.6 mmHg
Standard Error 1.3
|
-15.9 mmHg
Standard Error 1.4
|
Adverse Events
Telmisartan + HCTZ + Amlodipine - Double Blind Period
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Telmisartan + HCTZ + Placebo - Double Blind Period
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Telmisartan + HCTZ + Amlodipine - Extension Period
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Telmisartan + HCTZ + Placebo - Extension Period
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telmisartan + HCTZ + Amlodipine - Double Blind Period
n=68 participants at risk
Telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks (double blind period)
|
Telmisartan + HCTZ + Placebo - Double Blind Period
n=64 participants at risk
Telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks (double-blind period)
|
Telmisartan + HCTZ + Amlodipine - Extension Period
n=65 participants at risk
Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks in the double blind period. Adverse events which occurred in extension period were collected.
|
Telmisartan + HCTZ + Placebo - Extension Period
n=61 participants at risk
Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks in the double-blind period. Adverse events which occurred in extension period were collected.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/68 • Up to 60 weeks
|
0.00%
0/64 • Up to 60 weeks
|
0.00%
0/65 • Up to 60 weeks
|
1.6%
1/61 • Up to 60 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/68 • Up to 60 weeks
|
0.00%
0/64 • Up to 60 weeks
|
1.5%
1/65 • Up to 60 weeks
|
0.00%
0/61 • Up to 60 weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/68 • Up to 60 weeks
|
0.00%
0/64 • Up to 60 weeks
|
1.5%
1/65 • Up to 60 weeks
|
0.00%
0/61 • Up to 60 weeks
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/68 • Up to 60 weeks
|
0.00%
0/64 • Up to 60 weeks
|
0.00%
0/65 • Up to 60 weeks
|
1.6%
1/61 • Up to 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/68 • Up to 60 weeks
|
0.00%
0/64 • Up to 60 weeks
|
1.5%
1/65 • Up to 60 weeks
|
0.00%
0/61 • Up to 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/68 • Up to 60 weeks
|
0.00%
0/64 • Up to 60 weeks
|
1.5%
1/65 • Up to 60 weeks
|
0.00%
0/61 • Up to 60 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/68 • Up to 60 weeks
|
0.00%
0/64 • Up to 60 weeks
|
1.5%
1/65 • Up to 60 weeks
|
0.00%
0/61 • Up to 60 weeks
|
Other adverse events
| Measure |
Telmisartan + HCTZ + Amlodipine - Double Blind Period
n=68 participants at risk
Telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks (double blind period)
|
Telmisartan + HCTZ + Placebo - Double Blind Period
n=64 participants at risk
Telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks (double-blind period)
|
Telmisartan + HCTZ + Amlodipine - Extension Period
n=65 participants at risk
Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks in the double blind period. Adverse events which occurred in extension period were collected.
|
Telmisartan + HCTZ + Placebo - Extension Period
n=61 participants at risk
Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks in the double-blind period. Adverse events which occurred in extension period were collected.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.8%
6/68 • Up to 60 weeks
|
9.4%
6/64 • Up to 60 weeks
|
35.4%
23/65 • Up to 60 weeks
|
26.2%
16/61 • Up to 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.9%
2/68 • Up to 60 weeks
|
1.6%
1/64 • Up to 60 weeks
|
6.2%
4/65 • Up to 60 weeks
|
1.6%
1/61 • Up to 60 weeks
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER