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: September 17, 2014
Last verified: September 2014

March 15, 2011
September 17, 2014
March 2011
June 2014   (final data collection date for primary outcome measure)
The primary endpoint is the mean blood pressure change systolic blood pressure/diastolic blood pressure(SBP/DBP) from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
The primary endpoint is the mean blood pressure change systolic blood pressure/diastolic blood pressure(SBP/DBP) from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal (i.e. last observation carried forward). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01316419 on ClinicalTrials.gov Archive Site
  • The key secondary endpoints include the percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of greater than or equal to 10 mmHg). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of greater than or equal to 10 mmHg). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the change from baseline of quality of life assessment data measured by World Health Organization Quality of Life Assessment Instrument (WHOQOL-BREF) and EuroQol Visual Analogue Scale (EQ VAS). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the mean blood lipid change (High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, Triglycerides, and Total Cholesterol). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patients achieving normal Body Mass Index (18.5 kg/m2 to 24.9 kg/m2). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patients who complied with each category of lifestyle modification recommendations. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patient achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • Safety will be evaluated by the incidence and severity of reported adverse events. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of = 10 mmHg). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of = 10 mmHg). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoints include the change from baseline of quality of life assessment data measured by World Health Organization Quality of Life Assessment Instrument (WHOQOL-BREF) and EuroQol Visual Analogue Scale (EQ VAS). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the mean blood lipid change (High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, Triglycerides, and Total Cholesterol). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patients achieving normal Body Mass Index (18.5 kg/m2 to 24.9 kg/m2). [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • The other secondary endpoints include the percentage of patients who completely complied, partially complied, or who did not comply with lifestyle modification recommendations. [ Time Frame: 24±2 weeks ] [ Designated as safety issue: No ]
  • Safety will be evaluated by the incidence and severity of reported adverse events. [ Time Frame: 54±2 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension
An Observational Study to Evaluate the Effects of Twynsta Tablets (Telmisartan and Amlodipine FDC, q.d.) With Life Style Modifications on Blood Pressure, Quality of Life, and Other Risk Factors in Korean Patients With Hypertension

This observational study is designed to evaluate the effects of Twynsta tablets with life style modifications on blood pressure, quality of life, and other risk factors in Korean patients with hypertension in a routine clinical practice setting.

Study Design:

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Korean

Hypertension
Drug: Telmisartan and amlodipine
Telmisartan and amlodipine 40/5mg or 40/10mg or 80/5mg
Patients with essential hypertension
Intervention: Drug: Telmisartan and amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2089
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or telmisartan monotherapy (=140/90 mmHg, = 130/80 mmHg for those with diabetes or kidney disease)
  2. Age = 19 years at enrollment
  3. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent

Exclusion criteria:

  1. Patients with previous exposure to Twynsta
  2. Patients with hypersensitivity to the active substances, or to dihydropyridine derivatives
  3. Female patients at second and third trimesters of pregnancy
  4. Female patients with lactation
  5. Patients with biliary obstructive disorders
  6. Patients with severe hepatic impairment
  7. Patients with high grade aortic stenosis
  8. Patients with shock
  9. Patients with hereditary conditions such as intolerance with excipient of the products
  10. Current participation in other clinical trials or observational studies
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01316419
1235.42
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP