Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension - Full Text View

Purpose

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.

Condition	Intervention
Hypertension	Drug: Telmisartan and amlodipine


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	2089
Study Start Date:	March 2011
Study Completion Date:	June 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with essential hypertension	Drug: Telmisartan and amlodipine Telmisartan and amlodipine 40/5mg or 40/10mg or 80/5mg

Detailed Description:

Study Design:

Eligibility


Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Korean

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316419

Show 55 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

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
Last Updated:	September 17, 2014
Health Authority:	South Korea: Ministry of Food and Drug Safety (MFDS)

Additional relevant MeSH terms:


Hypertension Cardiovascular Diseases Vascular Diseases Amlodipine Telmisartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Antihypertensive Agents	Calcium Channel Blockers Cardiovascular Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on February 27, 2015