| Primary | 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. | 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. | All patients with a baseline and an endpoint blood pressure measurement. | Posted | | Mean | Standard Deviation | mmHg | | baseline and 24±2 weeks | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Paired t test | | <0.0001 | Mean SBP change from baseline at the last visit will be analyzed by paired t-test | | | | | 2-Sided | | | | | | | No | Superiority or Other | | |
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| Secondary | Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg. | Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint. | All patients with a baseline and an endpoint blood pressure measurement. | Posted | | Number | | percentage of participants | | 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Percentage of Patients Achieving DBP Response | Percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint. | All patients with a baseline and an endpoint blood pressure measurement. | Posted | | Number | | percentage of participants | | 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Primary | 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. | 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. | All patients with a baseline and an endpoint blood pressure measurement. | Posted | | Mean | Standard Deviation | mmHg | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Percentage of Patients Achieving SBP Response | Percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint. | All patients with a baseline and an endpoint blood pressure measurement. | Posted | | Number | | percentage of participants | | 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain | 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. | Patients with a baseline and an endpoint WHOQOL-BREF response | Posted | | Mean | Standard Deviation | scores on a scale | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain | 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. | All patients with a baseline and an endpoint blood pressure measurement. | Posted | | Mean | Standard Deviation | scores on a scale | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain | 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. | Patients with a baseline and an endpoint WHOQOL-BREF response | Posted | | Mean | Standard Deviation | scores on a scale | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain | 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. | Patients with a baseline and an endpoint WHOQOL-BREF response | Posted | | Mean | Standard Deviation | scores on a scale | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall | 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. | Patients with a baseline and an endpoint WHOQOL-BREF response | Posted | | Mean | Standard Deviation | scores on a scale | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | EuroQol (EQ) Visual Analogue Scale (VAS) | 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. | Patients with a baseline and an endpoint EQ VAS response | Posted | | Mean | Standard Deviation | scores on a scale | | baseline and 24±2 weeks | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease | Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease | All patients with diabetes, kidney disease or both (diabetes + kidney disease) | Posted | | Number | | percentage of participants | | 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol | Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol | 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. | Posted | | Mean | Standard Deviation | mg/dl | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol | Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol | 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. | Posted | | Mean | Standard Deviation | mg/dl | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Mean Blood Lipid Change - Triglyceride | Mean blood lipid change - Triglyceride | 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. | Posted | | Mean | Standard Deviation | mg/dl | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Mean Blood Lipid Change - Total Cholesterol | Mean blood lipid change - Total Cholesterol | 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. | Posted | | Mean | Standard Deviation | mg/dl | | baseline and 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Percentage of Patients Achieving Normal Body Mass Index (BMI) | Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented | Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications. | Posted | | Number | | percentage of participants | | 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks | Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks | Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications. | Posted | | Number | | percentage of participants | | 12±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks | Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks | Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications. | Posted | | Number | | percentage of participants | | 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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| Secondary | Incidence and Severity of Reported Adverse Events. | Incidence as per the severity of reported adverse events is presented. | Patients having received at least one dose of Twynsta tablets | Posted | | Number | | participants | | 24±2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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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