N/A
Completed N=2,089
Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension
Source: ClinicalTrials.gov NCT01316419 ↗Enrolled (actual)
2,089
Serious AEs
1.8%
Results posted
Jul 2015
Primary outcomePrimary: 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 — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
-21.81 | <0.0001 sig |
| 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. |
-13.48 | <0.0001 sig |
| SECONDARY Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg. |
74.07 | — |
| SECONDARY Percentage of Patients Achieving DBP Response |
88.99 | — |
| SECONDARY Percentage of Patients Achieving SBP Response |
87.18 | — |
| SECONDARY Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain |
0.07 | 0.1099 |
| SECONDARY Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain |
0.11 | 0.0197 sig |
| SECONDARY Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain |
-0.04 | 0.4543 |
| SECONDARY Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain |
0.12 | 0.0152 sig |
| SECONDARY Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall |
0.03 | 0.0013 sig |
| SECONDARY EuroQol (EQ) Visual Analogue Scale (VAS) |
4.64 | <0.0001 sig |
| SECONDARY Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease |
41.26; 40.00; 50.00 | — |
| SECONDARY Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol |
-9.17 | 0.0006 sig |
| SECONDARY Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol |
0.44 | 0.4248 |
| SECONDARY Mean Blood Lipid Change - Triglyceride |
-3.76 | 0.5579 |
| SECONDARY Mean Blood Lipid Change - Total Cholesterol |
-9.62 | 0.0006 sig |
| SECONDARY Percentage of Patients Achieving Normal Body Mass Index (BMI) |
45.62 | — |
| SECONDARY Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks |
71.87; 84.33; 71.08; 82.38 | — |
| SECONDARY Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks |
77.21; 87.38; 76.09; 83.49 | — |
| SECONDARY Incidence and Severity of Reported Adverse Events. |
220; 73; 9 | — |
Eligibility Criteria
Inclusion criteria
- 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)
- Age = 19 years at enrollment
- Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
Exclusion criteria
- Patients with previous exposure to Twynsta
- Patients with hypersensitivity to the active substances, or to dihydropyridine derivatives
- Female patients at second and third trimesters of pregnancy
- Female patients with lactation
- Patients with biliary obstructive disorders
- Patients with severe hepatic impairment
- Patients with high grade aortic stenosis
- Patients with shock
- Patients with hereditary conditions such as intolerance with excipient of the products
- Current participation in other clinical trials or observational studies
Data sourced from ClinicalTrials.gov (NCT01316419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.