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An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

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ClinicalTrials.gov Identifier: NCT01103960
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : September 20, 2012
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Telmisartan80mg+Amlodipine5mg
Drug: amlodipine 5mg
Drug: Telmisartan80mg+Amlodipine 5mg
Enrollment 324
Recruitment Details  
Pre-assignment Details Whilst there were 324 patients randomised and treated, there were only 314 in the Full analysis set (FAS).
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description Amlodipine 5mg monotherapy Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Period Title: Overall Study
Started 164 [1] 160 [1]
Completed 159 [2] 158 [2]
Not Completed 5 2
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             2             1
Other             1             0
[1]
Randomised and treated.
[2]
Completed study medication.
Arm/Group Title A5 Alone T80/A5 Total
Hide Arm/Group Description Amlodipine 5mg monotherapy Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination Total of all reporting groups
Overall Number of Baseline Participants 159 155 314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 155 participants 314 participants
52.4  (9.7) 52.4  (8.7) 52.4  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 155 participants 314 participants
Female
71
  44.7%
78
  50.3%
149
  47.5%
Male
88
  55.3%
77
  49.7%
165
  52.5%
Diastolic blood pressure (DBP)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 159 participants 155 participants 314 participants
97.84  (6.43) 97.21  (5.46) 97.53  (5.97)
Systolic blood pressure (SBP)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 159 participants 155 participants 314 participants
146.27  (11.15) 146.44  (12.20) 146.35  (11.66)
1.Primary Outcome
Title Change From Baseline in DBP After 8 Weeks of Treatment
Hide Description Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Time Frame Baseline and 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 159 155
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-10.19  (0.93) -12.38  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A5 Alone, T80/A5
Comments A5 minus T80/A5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments This was the first step in the closed testing procedure of multiple endpoints. The p-value was <0.05 so this test was considered confirmatory. Proceeding to the next step was allowed, testing the same endpoint in the subgroup of Chinese patients.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.1881
Confidence Interval 95%
0.6082 to 3.7681
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8030
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
Hide Description Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.
Time Frame Baseline and 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with LOCF and further restricted to the Chinese subgroup
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 133 129
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-8.85  (0.63) -10.77  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A5 Alone, T80/A5
Comments A5 minus T80/A5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments This was the second step in the closed testing procedure of multiple endpoints. The p-value was again <0.05 so this test was also considered confirmatory.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.9195
Confidence Interval 95%
0.1443 to 3.6947
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9015
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in SBP After 8 Weeks of Treatment
Hide Description Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Time Frame Baseline and 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with LOCF
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 159 155
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-11.66  (1.30) -16.15  (1.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A5 Alone, T80/A5
Comments A5 minus T80/A5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.4879
Confidence Interval 95%
2.2807 to 6.6950
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1217
Estimation Comments [Not Specified]
4.Secondary Outcome
Title DBP and SBP Control and Response After 8 Weeks of Treatment
Hide Description DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.
Time Frame Baseline and 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with LOCF
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 159 155
Measure Type: Number
Unit of Measure: Number of participants
DBP control 85 112
SBP control 100 119
DBP response 101 124
SBP response 120 131
5.Secondary Outcome
Title Number of Patients in Blood Pressure Categories Over Time
Hide Description BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with LOCF
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 159 155
Measure Type: Number
Unit of Measure: Number of participants
BP optimal 7 11
BP normal 33 36
BP high-normal 32 53
Grade 1 hypertension 69 48
Grade 2 hypertension 15 5
Grade 3 hypertension 3 2
6.Secondary Outcome
Title Change From Baseline in DBP After 4 Weeks of Treatment
Hide Description Seated trough DBP after 4 weeks.
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with LOCF
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 158 155
Mean (Standard Deviation)
Unit of Measure: mmHg
-7.51  (6.80) -9.41  (7.26)
7.Secondary Outcome
Title Change From Baseline in SBP After 4 Weeks of Treatment
Hide Description Seated trough SBP after 4 weeks.
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with LOCF
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 158 155
Mean (Standard Deviation)
Unit of Measure: mmHg
-8.19  (11.45) -12.10  (11.68)
8.Secondary Outcome
Title DBP and SBP Control and Response After 4 Weeks of Treatment
Hide Description DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with LOCF
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 159 155
Measure Type: Number
Unit of Measure: Number of participants
DBP control 71 95
SBP control 91 103
DBP response 87 108
SBP response 108 124
9.Secondary Outcome
Title Number of Patients in Blood Pressure Categories at 4 Weeks
Hide Description BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS with LOCF
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 159 155
Measure Type: Number
Unit of Measure: Number of participants
BP optimal 1 7
BP normal 20 26
BP high-normal 35 44
Grade 1 hypertension 81 62
Grade 2 hypertension 17 15
Grade 3 hypertension 5 1
10.Secondary Outcome
Title Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.
Hide Description Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Time Frame From drug administration until end of treatment plus one day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set included patients who were randomised and took at least one dose of the trial medication in the double-blind treatment period.
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description:
Amlodipine 5mg monotherapy
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
Overall Number of Participants Analyzed 164 160
Measure Type: Number
Unit of Measure: participants
Atrial fibrilation 0 1
Myocardial ischaemia 1 0
Blood glucose increased 1 4
Protein urine present 2 1
Alanine aminotransferase increased 0 1
Blood creatinine phosphokinase increased 1 0
Blood creatinine increased 0 1
Blood glucose abnormal 1 1
Heart rate increased 0 1
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A5 Alone T80/A5
Hide Arm/Group Description Amlodipine 5 mg one daily Telmisartan 80 mg plus Amlodipine 5 mg once daily
All-Cause Mortality
A5 Alone T80/A5
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A5 Alone T80/A5
Affected / at Risk (%) Affected / at Risk (%)
Total   0/164 (0.00%)   0/160 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A5 Alone T80/A5
Affected / at Risk (%) Affected / at Risk (%)
Total   0/164 (0.00%)   0/160 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01103960     History of Changes
Other Study ID Numbers: 1235.29
First Submitted: April 13, 2010
First Posted: April 15, 2010
Results First Submitted: August 21, 2012
Results First Posted: September 20, 2012
Last Update Posted: June 27, 2014