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Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT01316419
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : July 27, 2015
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Prospective
Condition Hypertension
Interventions Drug: Telmisartan
Drug: amlodipine
Enrollment 2089

Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 2089
Completed 1824
Not Completed 265
Reason Not Completed
Not treated             103
Violated inclusion/exclusion criterion             143
Lost to Follow-up             19
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1824
Hide Baseline Analysis Population Description
All treated patients fulfilling the inclusion-exclusion criterias and who have completed the follow-up visits of the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1824 participants
57.65  (13.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1824 participants
Female
778
  42.7%
Male
1046
  57.3%
1.Primary Outcome
Title 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.
Hide Description

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.

Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with a baseline and an endpoint blood pressure measurement.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1662
Mean (Standard Deviation)
Unit of Measure: mmHg
-21.81  (16.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mean SBP change from baseline at the last visit will be analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
2.Primary Outcome
Title 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.
Hide Description

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.

Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with a baseline and an endpoint blood pressure measurement.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1662
Mean (Standard Deviation)
Unit of Measure: mmHg
-13.48  (11.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mean DBP change from baseline at the last visit will be analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.
Hide Description Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint.
Time Frame 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with a baseline and an endpoint blood pressure measurement.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1662
Measure Type: Number
Unit of Measure: percentage of participants
74.07
4.Secondary Outcome
Title Percentage of Patients Achieving DBP Response
Hide Description Percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.
Time Frame 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with a baseline and an endpoint blood pressure measurement.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1662
Measure Type: Number
Unit of Measure: percentage of participants
88.99
5.Secondary Outcome
Title Percentage of Patients Achieving SBP Response
Hide Description Percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.
Time Frame 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with a baseline and an endpoint blood pressure measurement.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1662
Measure Type: Number
Unit of Measure: percentage of participants
87.18
6.Secondary Outcome
Title Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain
Hide Description

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.

Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline and an endpoint WHOQOL-BREF response
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1490
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.07  (1.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1099
Comments The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain
Hide Description

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.

Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with a baseline and an endpoint blood pressure measurement.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1490
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.11  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0197
Comments The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain
Hide Description

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.

Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline and an endpoint WHOQOL-BREF response
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1489
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.04  (2.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4543
Comments The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain
Hide Description

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.

Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline and an endpoint WHOQOL-BREF response
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1490
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.12  (1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0152
Comments The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall
Hide Description

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.

Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline and an endpoint WHOQOL-BREF response
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1490
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.03  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
11.Secondary Outcome
Title EuroQol (EQ) Visual Analogue Scale (VAS)
Hide Description 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.
Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline and an endpoint EQ VAS response
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1489
Mean (Standard Deviation)
Unit of Measure: scores on a scale
4.64  (16.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The change of QOL data collected using the EQ VAS is analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease
Hide Description Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease
Time Frame 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with diabetes, kidney disease or both (diabetes + kidney disease)
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 299
Measure Type: Number
Unit of Measure: percentage of participants
Diabetes (N=269) 41.26
Kidney Disease (N=20) 40.00
Diabetes + Kidney disease (N=10) 50.00
13.Secondary Outcome
Title Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol
Hide Description Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol
Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: mg/dl
-9.17  (29.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments Mean LDL-C change from baseline at the last visit will be analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
14.Secondary Outcome
Title Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol
Hide Description Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol
Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 134
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.44  (6.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4248
Comments Mean HDL-C change from baseline at the last visit will be analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
15.Secondary Outcome
Title Mean Blood Lipid Change - Triglyceride
Hide Description Mean blood lipid change - Triglyceride
Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 134
Mean (Standard Deviation)
Unit of Measure: mg/dl
-3.76  (74.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5579
Comments Mean Triglyceride change from baseline at the last visit will be analyzed by paired t-test
Method Paired t test
Comments [Not Specified]
16.Secondary Outcome
Title Mean Blood Lipid Change - Total Cholesterol
Hide Description Mean blood lipid change - Total Cholesterol
Time Frame baseline and 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: mg/dl
-9.62  (30.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Twynsta (Telmisartan and Amlodipine FDC) Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments Mean total cholesterol change from baseline at the last visit will be analyzed by paired t-test
Method Paired t-test
Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Patients Achieving Normal Body Mass Index (BMI)
Hide Description Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented
Time Frame 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1392
Measure Type: Number
Unit of Measure: percentage of participants
45.62
18.Secondary Outcome
Title Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks
Hide Description Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks
Time Frame 12±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1646
Measure Type: Number
Unit of Measure: percentage of participants
Physical activity 71.87
Well balanced diet 84.33
Dietary sodium reduction 71.08
Moderation of alcohol consumption 82.38
19.Secondary Outcome
Title Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks
Hide Description Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks
Time Frame 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1514
Measure Type: Number
Unit of Measure: percentage of participants
Physical activity 77.21
Well balanced diet 87.38
Dietary sodium reduction 76.09
Moderation of alcohol consumption 83.49
20.Secondary Outcome
Title Incidence and Severity of Reported Adverse Events.
Hide Description Incidence as per the severity of reported adverse events is presented.
Time Frame 24±2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients having received at least one dose of Twynsta tablets
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1824
Measure Type: Number
Unit of Measure: participants
Mild 220
Moderate 73
Severe 9
Time Frame 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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Twynsta (Telmisartan and Amlodipine FDC) Tablets
Hide Arm/Group Description 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.
All-Cause Mortality
Twynsta (Telmisartan and Amlodipine FDC) Tablets
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Twynsta (Telmisartan and Amlodipine FDC) Tablets
Affected / at Risk (%)
Total   33/1824 (1.81%) 
Cardiac disorders   
Angina pectoris  1  2/1824 (0.11%) 
Coronary artery stenosis  1  1/1824 (0.05%) 
Eye disorders   
Cataract  1  1/1824 (0.05%) 
Visual impairment  1  1/1824 (0.05%) 
Gastrointestinal disorders   
Vomiting  1  1/1824 (0.05%) 
General disorders   
Asthenia  1  1/1824 (0.05%) 
Chest discomfort  1  1/1824 (0.05%) 
Infections and infestations   
Pneumonia  1  2/1824 (0.11%) 
Arthritis bacterial  1  1/1824 (0.05%) 
Ophthalmic herpes zoster  1  1/1824 (0.05%) 
Otitis media  1  1/1824 (0.05%) 
Urinary tract infection  1  1/1824 (0.05%) 
Injury, poisoning and procedural complications   
Fall  1  2/1824 (0.11%) 
Patella fracture  1  1/1824 (0.05%) 
Humerus fracture  1  1/1824 (0.05%) 
Lower limb fracture  1  1/1824 (0.05%) 
Radius fracture  1  1/1824 (0.05%) 
Thoracic vertebral fracture  1  1/1824 (0.05%) 
Tibia fracture  1  1/1824 (0.05%) 
Wound dehiscence  1  1/1824 (0.05%) 
Musculoskeletal and connective tissue disorders   
Lumbar spinal stenosis  1  1/1824 (0.05%) 
Rotator cuff syndrome  1  1/1824 (0.05%) 
Arthritis  1  1/1824 (0.05%) 
Osteoarthritis  1  1/1824 (0.05%) 
Spondylolisthesis  1  1/1824 (0.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cervix carcinoma  1  1/1824 (0.05%) 
Fibromatosis  1  1/1824 (0.05%) 
Gastric cancer  1  1/1824 (0.05%) 
Transitional cell carcinoma  1  1/1824 (0.05%) 
Uterine leiomyoma  1  1/1824 (0.05%) 
Nervous system disorders   
Dizziness  1  1/1824 (0.05%) 
Cerebral infarction  1  3/1824 (0.16%) 
Cerebrovascular accident  1  2/1824 (0.11%) 
Reproductive system and breast disorders   
Erectile dysfunction  1  1/1824 (0.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Twynsta (Telmisartan and Amlodipine FDC) Tablets
Affected / at Risk (%)
Total   0/1824 (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.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01316419     History of Changes
Other Study ID Numbers: 1235.42
First Submitted: March 15, 2011
First Posted: March 16, 2011
Results First Submitted: June 26, 2015
Results First Posted: July 27, 2015
Last Update Posted: September 21, 2015