Hypertension Clinical Trial
Official title:
A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Investigate the Safety and Efficacy Between YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia
Verified date | July 2014 |
Source | Yuhan Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Ministry of Food and Drug Safety |
Study type | Interventional |
To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia
Status | Completed |
Enrollment | 210 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Signed Informed Consent - Men and women = 19 years of age - Subject who has one of 3 conditions classified by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, TG, Coronary Artery Disease and Equivalent Exclusion Criteria: - Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study. - Other exclusions applied |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yuhan Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Diastolic Blood Pressure, Change in LDL Cholesterol | Change from Baseline at 8 weeks | Yes |
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