Trial Outcomes & Findings for Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension (NCT NCT01316419)
NCT ID: NCT01316419
Last Updated: 2015-09-21
Results Overview
The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. Baseline is defined as data collected on baseline visit.
COMPLETED
2089 participants
baseline and 24±2 weeks
2015-09-21
Participant Flow
This is an observational study to evaluate the effects of Twynsta tablets (Telmisartan and amlodipine fixed dose combination (FDC), once daily (q.d.)) with life style modifications on blood pressure, quality of life, and other risk factors in Korean patients with hypertension
Participant milestones
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Overall Study
STARTED
|
2089
|
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Overall Study
COMPLETED
|
1824
|
|
Overall Study
NOT COMPLETED
|
265
|
Reasons for withdrawal
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Overall Study
Not treated
|
103
|
|
Overall Study
Violated inclusion/exclusion criterion
|
143
|
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Overall Study
Lost to Follow-up
|
19
|
Baseline Characteristics
Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension
Baseline characteristics by cohort
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1824 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Age, Continuous
|
57.65 years
STANDARD_DEVIATION 13.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
778 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
1046 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 24±2 weeksPopulation: All patients with a baseline and an endpoint blood pressure measurement.
The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. Baseline is defined as data collected on baseline visit.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1662 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
|
Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.
|
-21.81 mmHg
Standard Deviation 16.12
|
PRIMARY outcome
Timeframe: baseline and 24±2 weeksPopulation: All patients with a baseline and an endpoint blood pressure measurement.
The primary endpoint is the mean blood pressure change DBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. Baseline is defined as data collected on baseline visit.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1662 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
|
Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.
|
-13.48 mmHg
Standard Deviation 11.65
|
SECONDARY outcome
Timeframe: 24±2 weeksPopulation: All patients with a baseline and an endpoint blood pressure measurement.
Percentage of patients achieving target blood pressure SBP/DBP \<140/90 mmHg is a key secondary endpoint.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1662 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
|
Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.
|
74.07 percentage of participants
|
SECONDARY outcome
Timeframe: 24±2 weeksPopulation: All patients with a baseline and an endpoint blood pressure measurement.
Percentage of patients achieving DBP response (defined as mean seated DBP \< 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1662 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
|
Percentage of Patients Achieving DBP Response
|
88.99 percentage of participants
|
SECONDARY outcome
Timeframe: 24±2 weeksPopulation: All patients with a baseline and an endpoint blood pressure measurement.
Percentage of patients achieving SBP response (defined as mean seated SBP \< 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1662 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Percentage of Patients Achieving SBP Response
|
87.18 percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with a baseline and an endpoint WHOQOL-BREF response
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1490 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain
|
0.07 scores on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: All patients with a baseline and an endpoint blood pressure measurement.
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1490 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
|
|---|---|
|
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain
|
0.11 scores on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with a baseline and an endpoint WHOQOL-BREF response
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1489 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
|
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain
|
-0.04 scores on a scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with a baseline and an endpoint WHOQOL-BREF response
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1490 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain
|
0.12 scores on a scale
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with a baseline and an endpoint WHOQOL-BREF response
WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life. The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1490 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
|
|---|---|
|
Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall
|
0.03 scores on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with a baseline and an endpoint EQ VAS response
The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'best imaginable health state' and 'worst imaginable health state. The scale goes from 0 to 100, a low value shows better physical health.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1489 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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EuroQol (EQ) Visual Analogue Scale (VAS)
|
4.64 scores on a scale
Standard Deviation 16.24
|
SECONDARY outcome
Timeframe: 24±2 weeksPopulation: All patients with diabetes, kidney disease or both (diabetes + kidney disease)
Percentage of patients achieving SBP/DBP \< 130/80 mmHg among patients with diabetes or kidney disease
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=299 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
Diabetes (N=269)
|
41.26 percentage of participants
|
|
Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
Kidney Disease (N=20)
|
40.00 percentage of participants
|
|
Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
Diabetes + Kidney disease (N=10)
|
50.00 percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.
Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=124 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol
|
-9.17 mg/dl
Standard Deviation 29.16
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.
Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=134 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol
|
0.44 mg/dl
Standard Deviation 6.34
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.
Mean blood lipid change - Triglyceride
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=134 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
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Mean Blood Lipid Change - Triglyceride
|
-3.76 mg/dl
Standard Deviation 74.12
|
SECONDARY outcome
Timeframe: baseline and 24±2 weeksPopulation: Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.
Mean blood lipid change - Total Cholesterol
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=123 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
|
|---|---|
|
Mean Blood Lipid Change - Total Cholesterol
|
-9.62 mg/dl
Standard Deviation 30.19
|
SECONDARY outcome
Timeframe: 24±2 weeksPopulation: Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1392 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
|
Percentage of Patients Achieving Normal Body Mass Index (BMI)
|
45.62 percentage of participants
|
SECONDARY outcome
Timeframe: 12±2 weeksPopulation: Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1646 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
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|---|---|
|
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks
Well balanced diet
|
84.33 percentage of participants
|
|
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks
Physical activity
|
71.87 percentage of participants
|
|
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks
Dietary sodium reduction
|
71.08 percentage of participants
|
|
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks
Moderation of alcohol consumption
|
82.38 percentage of participants
|
SECONDARY outcome
Timeframe: 24±2 weeksPopulation: Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1514 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
|
|---|---|
|
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
Physical activity
|
77.21 percentage of participants
|
|
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
Well balanced diet
|
87.38 percentage of participants
|
|
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
Dietary sodium reduction
|
76.09 percentage of participants
|
|
Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
Moderation of alcohol consumption
|
83.49 percentage of participants
|
SECONDARY outcome
Timeframe: 24±2 weeksPopulation: Patients having received at least one dose of Twynsta tablets
Incidence as per the severity of reported adverse events is presented.
Outcome measures
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1824 Participants
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
|
|---|---|
|
Incidence and Severity of Reported Adverse Events.
Mild
|
220 participants
|
|
Incidence and Severity of Reported Adverse Events.
Moderate
|
73 participants
|
|
Incidence and Severity of Reported Adverse Events.
Severe
|
9 participants
|
Adverse Events
Twynsta (Telmisartan and Amlodipine FDC) Tablets
Serious adverse events
| Measure |
Twynsta (Telmisartan and Amlodipine FDC) Tablets
n=1824 participants at risk
Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
|
|---|---|
|
Nervous system disorders
Dizziness
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.16%
3/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
2/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Infections and infestations
Pneumonia
|
0.11%
2/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Infections and infestations
Arthritis bacterial
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Infections and infestations
Otitis media
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
General disorders
Asthenia
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
General disorders
Chest discomfort
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
2/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.11%
2/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibromatosis
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Eye disorders
Cataract
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Eye disorders
Visual impairment
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.05%
1/1824 • All adverse events occurring during the course of the observational study (i.e., from signing the informed consent onwards through the observational phase); Up to 24±2 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
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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