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

IlDong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Rosuvastatin 10mg; Drug: Placebo(for Rosuvastatin 10mg); Drug: Telmisartan 80mg; Drug: Placebo(for Telmisartan 80mg); Drug: Placebo(for Rosuvastatin 20mg); Drug: Rosuvastatin 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02087540

ID_Telotan_1203

Details and patient eligibility

About

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

Enrollment: 310 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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310 participants in 6 patient groups, including a placebo group

Telmisartan 80mg & Rosuvastatin 20mg

Experimental group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Rosuvastatin 20mg

Drug: Placebo(for Rosuvastatin 10mg)

Drug: Telmisartan 80mg

Telmisartan 80mg & Rosuvastatin 10mg

Experimental group

Description:

PO, Once Daily, 8weeks

Treatment:

Drug: Rosuvastatin 10mg

Drug: Telmisartan 80mg

Drug: Placebo(for Rosuvastatin 20mg)

Telmisartan placebo & Rosuvastatin 20mg

Active Comparator group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Placebo(for Telmisartan 80mg)

Drug: Rosuvastatin 20mg

Drug: Placebo(for Rosuvastatin 10mg)

Telmisartan Placebo & Rosuvastatin 10mg

Active Comparator group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Placebo(for Telmisartan 80mg)

Drug: Rosuvastatin 10mg

Drug: Placebo(for Rosuvastatin 20mg)

Telmisartan 80mg & Rosuvastatin placebo

Active Comparator group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Placebo(for Telmisartan 80mg)

Drug: Telmisartan 80mg

Drug: Placebo(for Rosuvastatin 20mg)

Telmisartan placebo & Rosuvastatin placebo

Placebo Comparator group

Description:

PO, Once Daily, 8 weeks

Treatment:

Drug: Placebo(for Telmisartan 80mg)

Drug: Placebo(for Rosuvastatin 10mg)

Drug: Placebo(for Rosuvastatin 20mg)