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

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

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

Study Overview

• Status: Unknown
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Drug: Rosuvastatin 10mg; Drug: Rosuvastatin 20mg; Drug: Telmisartan 80mg; Drug: Placebo(for Rosuvastatin 10mg); Drug: Placebo(for Rosuvastatin 20mg); Drug: Placebo(for Telmisartan 80mg)

• Study Type: Interventional
• Enrollment (Anticipated): 310
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic University of Saint Mary's Hosiptal
    • Contact: wook-seong chung, MD; Email: chungws@catholic.ac.kr
    • Principal Investigator: wook-seong Chung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telmisartan 80mg & Rosuvastatin 20mg; PO, Once Daily, 8 weeks	Drug: Rosuvastatin 20mg; Drug: Telmisartan 80mg; Drug: Placebo(for Rosuvastatin 10mg)
Experimental: Telmisartan 80mg & Rosuvastatin 10mg; PO, Once Daily, 8weeks	Drug: Rosuvastatin 10mg; Drug: Telmisartan 80mg; Drug: Placebo(for Rosuvastatin 20mg)
Active Comparator: Telmisartan placebo & Rosuvastatin 20mg; PO, Once Daily, 8 weeks	Drug: Rosuvastatin 20mg; Drug: Placebo(for Rosuvastatin 10mg); Drug: Placebo(for Telmisartan 80mg)
Active Comparator: Telmisartan Placebo & Rosuvastatin 10mg; PO, Once Daily, 8 weeks	Drug: Rosuvastatin 10mg; Drug: Placebo(for Rosuvastatin 20mg); Drug: Placebo(for Telmisartan 80mg)
Active Comparator: Telmisartan 80mg & Rosuvastatin placebo; PO, Once Daily, 8 weeks	Drug: Telmisartan 80mg; Drug: Placebo(for Rosuvastatin 20mg); Drug: Placebo(for Telmisartan 80mg)
Placebo Comparator: Telmisartan placebo & Rosuvastatin placebo; PO, Once Daily, 8 weeks	Drug: Placebo(for Rosuvastatin 10mg); Drug: Placebo(for Rosuvastatin 20mg); Drug: Placebo(for Telmisartan 80mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
•Change in seated diastolicblood pressure at 8 weeks compared to the base value	at the 8 weeks
Change in LDL-Cat 8 weeks compared to the base value (% change)	at the 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in seateddiastolic blood pressure	at 2,4 8 weeks
Change in seated systolic blood pressure	at 2,4,8weeks
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
Change in LDL-Cat compared to the base value (% change)	2, 4 and 8 weeks
Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change)	at 2, 4 and 8 weeks
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

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Estimate): March 14, 2014
• Last Update Submitted That Met QC Criteria: March 13, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Rosuvastatin Calcium; Telmisartan
• Other Study ID Numbers: ID_Telotan_1203