Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

Boehringer Ingelheim

Status: Completed

Conditions: Hypertension

Treatments: Drug: Telmisartan; Drug: amlodipine

Study type: Observational

Funder types: Industry

Identifiers

NCT01316419

1235.42

Details and patient eligibility

About

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.

Full description

Study Design:

Enrollment: 2,089 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,089 participants in 1 patient group

Patients with essential hypertension

Treatment:

Drug: Telmisartan

Drug: amlodipine