Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02087540
• Other study ID #: ID_Telotan_1203
• Status: Recruiting
• Phase: Phase 3
• First received: March 5, 2014
• Last updated: March 13, 2014
• Start date: May 2013

Study information

• Verified date: March 2014
• Source: IlDong Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Signed Informed Consent

• Men and women >18 years of age

• Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent

Exclusion Criteria:

• Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.

• Other exclusions applied

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• Telmisartan 80mg

• Rosuvastatin 20mg

• Rosuvastatin 10mg

• Placebo(for Telmisartan 80mg)

• Placebo(for Rosuvastatin 20mg)

• Placebo(for Rosuvastatin 10mg)

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Saint Mary's Hosiptal	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	•Change in seated diastolicblood pressure at 8 weeks compared to the base value		at the 8 weeks	Yes
Primary	Change in LDL-Cat 8 weeks compared to the base value (% change)		at the 8 weeks	Yes
Secondary	Change in seateddiastolic blood pressure		at 2,4 8 weeks	No
Secondary	Change in seated systolic blood pressure		at 2,4,8weeks	No
Secondary	Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)]		at 2, 4 and 8 weeks	No
Secondary	Change in LDL-Cat compared to the base value (% change)		2, 4 and 8 weeks	No
Secondary	Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change)		at 2, 4 and 8 weeks	No
Secondary	Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL)		at 2, 4 and 8 weeks	No