Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01316419
First received: March 15, 2011
Last updated: June 26, 2015
Last verified: June 2015
Results First Received: June 26, 2015  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Hypertension
Intervention: Drug: Telmisartan and amlodipine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Twynsta (Telmisartan and Amlodipine FDC) Tablets  
STARTED     2089  
COMPLETED     1824  
NOT COMPLETED     265  
Not treated                 103  
Violated inclusion/exclusion criterion                 143  
Lost to Follow-up                 19  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated patients fulfilling the inclusion-exclusion criterias and who have completed the follow-up visits of the study.

Reporting Groups
  Description
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.

Baseline Measures
    Twynsta (Telmisartan and Amlodipine FDC) Tablets  
Number of Participants  
[units: participants]
  1824  
Age  
[units: years]
Mean (Standard Deviation)
  57.65  (13.38)  
Gender  
[units: participants]
 
Female     778  
Male     1046  



  Outcome Measures
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1.  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.   [ Time Frame: baseline and 24±2 weeks ]

2.  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.   [ Time Frame: baseline and 24±2 weeks ]

3.  Secondary:   Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.   [ Time Frame: 24±2 weeks ]

4.  Secondary:   Percentage of Patients Achieving DBP Response   [ Time Frame: 24±2 weeks ]

5.  Secondary:   Percentage of Patients Achieving SBP Response   [ Time Frame: 24±2 weeks ]

6.  Secondary:   Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain   [ Time Frame: baseline and 24±2 weeks ]

7.  Secondary:   Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain   [ Time Frame: baseline and 24±2 weeks ]

8.  Secondary:   Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain   [ Time Frame: baseline and 24±2 weeks ]

9.  Secondary:   Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain   [ Time Frame: baseline and 24±2 weeks ]

10.  Secondary:   Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall   [ Time Frame: baseline and 24±2 weeks ]

11.  Secondary:   EuroQol (EQ) Visual Analogue Scale (VAS)   [ Time Frame: baseline and 24±2 weeks ]

12.  Secondary:   Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease   [ Time Frame: 24±2 weeks ]

13.  Secondary:   Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol   [ Time Frame: baseline and 24±2 weeks ]

14.  Secondary:   Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol   [ Time Frame: baseline and 24±2 weeks ]

15.  Secondary:   Mean Blood Lipid Change - Triglyceride   [ Time Frame: baseline and 24±2 weeks ]

16.  Secondary:   Mean Blood Lipid Change - Total Cholesterol   [ Time Frame: baseline and 24±2 weeks ]

17.  Secondary:   Percentage of Patients Achieving Normal Body Mass Index (BMI)   [ Time Frame: 24±2 weeks ]

18.  Secondary:   Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks   [ Time Frame: 12±2 weeks ]

19.  Secondary:   Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks   [ Time Frame: 24±2 weeks ]

20.  Secondary:   Incidence and Severity of Reported Adverse Events.   [ Time Frame: 24±2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01316419     History of Changes
Other Study ID Numbers: 1235.42
Study First Received: March 15, 2011
Results First Received: June 26, 2015
Last Updated: June 26, 2015
Health Authority: South Korea: Ministry of Food and Drug Safety (MFDS)