Trial Outcomes & Findings for Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension (NCT NCT01353274)
NCT ID: NCT01353274
Last Updated: 2014-08-18
Results Overview
Number of patients with drug-related adverse events
Recruitment status
COMPLETED
Target enrollment
1157 participants
Primary outcome timeframe
12 months
Results posted on
2014-08-18
Participant Flow
Participant milestones
| Measure |
Patients With Hypertension
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Overall Study
STARTED
|
1157
|
|
Overall Study
COMPLETED
|
1129
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Patients With Hypertension
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Overall Study
No case report form (CRF) collected
|
28
|
Baseline Characteristics
Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension
Baseline characteristics by cohort
| Measure |
Patients With Hypertension
n=1109 Participants
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
514 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
595 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Safety set: all patients who were documented to have taken at least one dose of T40/A5 mg FDC except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact
Number of patients with drug-related adverse events
Outcome measures
| Measure |
Patients With Hypertension
n=1109 Participants
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Incidence of Drug-related Adverse Events
|
60 participants
|
SECONDARY outcome
Timeframe: after 1, 2, 3, 6, 12 monthsPopulation: Efficacy set: all patients in the safety set who were labelled by T40/A5 mg Fixed Dose Combination (FDC) and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
Change from baseline in SBP after 1, 2, 3, 6, 12 months
Outcome measures
| Measure |
Patients With Hypertension
n=1108 Participants
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP)
Month 1
|
-15.9 mmHg
Standard Deviation 18.5
|
|
Change From Baseline in Systolic Blood Pressure (SBP)
Month 2
|
-16.5 mmHg
Standard Deviation 18.6
|
|
Change From Baseline in Systolic Blood Pressure (SBP)
Month 3
|
-16.7 mmHg
Standard Deviation 19.5
|
|
Change From Baseline in Systolic Blood Pressure (SBP)
Month 6
|
-17.7 mmHg
Standard Deviation 20.0
|
|
Change From Baseline in Systolic Blood Pressure (SBP)
Month 12
|
-19.2 mmHg
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: after 1, 2, 3, 6, 12 monthsPopulation: Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
Change from baseline in DBP after 1, 2, 3, 6, 12 months
Outcome measures
| Measure |
Patients With Hypertension
n=1108 Participants
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP)
Month 1
|
-7.6 mmHg
Standard Deviation 11.7
|
|
Change From Baseline in Diastolic Blood Pressure (DBP)
Month 2
|
-8.4 mmHg
Standard Deviation 12.2
|
|
Change From Baseline in Diastolic Blood Pressure (DBP)
Month 3
|
-8.2 mmHg
Standard Deviation 12.2
|
|
Change From Baseline in Diastolic Blood Pressure (DBP)
Month 6
|
-8.9 mmHg
Standard Deviation 12.7
|
|
Change From Baseline in Diastolic Blood Pressure (DBP)
Month 12
|
-9.8 mmHg
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: after 1, 2, 3, 6, 12 monthsPopulation: Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months
Outcome measures
| Measure |
Patients With Hypertension
n=1108 Participants
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Proportion of Patients Who Achieved the Target BP
Month 1
|
54.2 Percentage of patients (target BP)
|
|
Proportion of Patients Who Achieved the Target BP
Month 2
|
57.8 Percentage of patients (target BP)
|
|
Proportion of Patients Who Achieved the Target BP
Month 3
|
58.8 Percentage of patients (target BP)
|
|
Proportion of Patients Who Achieved the Target BP
Month 6
|
62.4 Percentage of patients (target BP)
|
|
Proportion of Patients Who Achieved the Target BP
Month 12
|
66.5 Percentage of patients (target BP)
|
SECONDARY outcome
Timeframe: after 1, 2, 3, 6, 12 monthsPopulation: Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months
Outcome measures
| Measure |
Patients With Hypertension
n=1108 Participants
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Proportion of Patients Who Normalised Their BP
Month 12
|
73.7 Percentage of patients (normalised BP)
|
|
Proportion of Patients Who Normalised Their BP
Month 1
|
61.3 Percentage of patients (normalised BP)
|
|
Proportion of Patients Who Normalised Their BP
Month 2
|
66.3 Percentage of patients (normalised BP)
|
|
Proportion of Patients Who Normalised Their BP
Month 3
|
67.2 Percentage of patients (normalised BP)
|
|
Proportion of Patients Who Normalised Their BP
Month 6
|
70.4 Percentage of patients (normalised BP)
|
Adverse Events
Patients With Hypertension
Serious events: 22 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Hypertension
n=1109 participants at risk
Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.18%
2/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.18%
2/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrage
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Immune system disorders
Anaphylactic shock
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.18%
2/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Nervous system disorders
Dementia
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Renal and urinary disorders
Renal failure chronic
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
|
Vascular disorders
Aortic dissection
|
0.09%
1/1109 • During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks
|
Other adverse events
Adverse event data not reported
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 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