Trial Outcomes & Findings for Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use (NCT NCT01050062)
NCT ID: NCT01050062
Last Updated: 2014-05-01
Results Overview
The number of patient with any AEs, patients with drug-related AEs
Recruitment status
COMPLETED
Target enrollment
1452 participants
Primary outcome timeframe
Week 52
Results posted on
2014-05-01
Participant Flow
A total of 1452 patients were enrolled. Of these patients, the CRFs of 9 patients were uncollected by reason of institution, and the 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey.
Participant milestones
| Measure |
Combination Tablet AP
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
|---|---|---|
|
Overall Study
STARTED
|
1070
|
355
|
|
Overall Study
COMPLETED
|
799
|
243
|
|
Overall Study
NOT COMPLETED
|
271
|
112
|
Reasons for withdrawal
| Measure |
Combination Tablet AP
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
75
|
22
|
|
Overall Study
Lost to Follow-up
|
83
|
35
|
|
Overall Study
Lack of Efficacy
|
22
|
35
|
|
Overall Study
Physician Decision
|
74
|
9
|
|
Overall Study
Others
|
17
|
11
|
Baseline Characteristics
Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use
Baseline characteristics by cohort
| Measure |
Combination Tablet AP
n=1070 Participants
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
n=355 Participants
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
Total
n=1425 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
69.8 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
68.9 years
STANDARD_DEVIATION 12.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
570 Participants
n=93 Participants
|
186 Participants
n=4 Participants
|
756 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
500 Participants
n=93 Participants
|
169 Participants
n=4 Participants
|
669 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The all treated patients, 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey
The number of patient with any AEs, patients with drug-related AEs
Outcome measures
| Measure |
Combination Tablet AP
n=1070 Participants
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
n=355 Participants
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
Total
n=1425 Participants
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
|
|---|---|---|---|
|
Incidence of Adverse Events (AEs)
patient with any AEs
|
221 Patients
|
72 Patients
|
293 Patients
|
|
Incidence of Adverse Events (AEs)
patients with drug-related AEs
|
154 Patients
|
46 Patients
|
200 Patients
|
SECONDARY outcome
Timeframe: Week 0 and Week 52Population: The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.
Outcome measures
| Measure |
Combination Tablet AP
n=1060 Participants
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
n=352 Participants
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
Total
n=1412 Participants
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
|
|---|---|---|---|
|
Systolic Blood Pressure (SBP)
Week 0
|
152.9 mmHg
Standard Deviation 18.3
|
155.4 mmHg
Standard Deviation 18.7
|
153.5 mmHg
Standard Deviation 18.4
|
|
Systolic Blood Pressure (SBP)
Week 52
|
132.2 mmHg
Standard Deviation 15.1
|
134.7 mmHg
Standard Deviation 15.5
|
132.8 mmHg
Standard Deviation 15.2
|
|
Systolic Blood Pressure (SBP)
Change from Week 0 to Week 52
|
-20.7 mmHg
Standard Deviation 18.8
|
-20.7 mmHg
Standard Deviation 21.5
|
-20.7 mmHg
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: Week 0 and Week 52Population: The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.
Outcome measures
| Measure |
Combination Tablet AP
n=1060 Participants
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
n=352 Participants
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
Total
n=1412 Participants
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
|
|---|---|---|---|
|
Diastolic Blood Pressure (DBP)
Week 52
|
75.2 mmHg
Standard Deviation 10.9
|
75.5 mmHg
Standard Deviation 11.2
|
75.3 mmHg
Standard Deviation 11.0
|
|
Diastolic Blood Pressure (DBP)
Change from Week 0 to Week 52
|
-9.5 mmHg
Standard Deviation 11.6
|
-9.1 mmHg
Standard Deviation 13.9
|
-9.4 mmHg
Standard Deviation 12.2
|
|
Diastolic Blood Pressure (DBP)
Week 0
|
84.7 mmHg
Standard Deviation 13.0
|
84.6 mmHg
Standard Deviation 12.8
|
84.7 mmHg
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Week 52Population: The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for \>= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.
Outcome measures
| Measure |
Combination Tablet AP
n=1060 Participants
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
n=352 Participants
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
Total
n=1412 Participants
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
|
|---|---|---|---|
|
Target Blood Pressure Achievement Rate
|
52.9 Percentage of patients
|
43.2 Percentage of patients
|
50.5 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 52Population: The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009
Outcome measures
| Measure |
Combination Tablet AP
n=1060 Participants
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
n=352 Participants
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
Total
n=1412 Participants
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
|
|---|---|---|---|
|
Blood Pressure Normalised Rate
|
70.7 percentage of participants
|
61.1 percentage of participants
|
68.3 percentage of participants
|
Adverse Events
Combination Tablet Ap
Serious events: 25 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination Tablet BP
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Total
Serious events: 37 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Tablet Ap
n=1070 participants at risk
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
|
Combination Tablet BP
n=355 participants at risk
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
|
Total
n=1425 participants at risk
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Cardiac disorders
Sick sinus syndrome
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
General disorders
Death
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
2/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.14%
2/1425 • 52 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.19%
2/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.21%
3/1425 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.19%
2/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.21%
3/1425 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
3/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.28%
4/1425 • 52 weeks
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Psychiatric disorders
Completed suicide
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Renal and urinary disorders
Renal failure chronic
|
0.09%
1/1070 • 52 weeks
|
0.28%
1/355 • 52 weeks
|
0.14%
2/1425 • 52 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.09%
1/1070 • 52 weeks
|
0.00%
0/355 • 52 weeks
|
0.07%
1/1425 • 52 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
- Publication restrictions are in place