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

NCT ID: NCT02087540

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Brief Summary

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

Detailed Description

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Conditions

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Hypertension Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Telmisartan 80mg & Rosuvastatin 20mg

PO, Once Daily, 8 weeks

Group Type EXPERIMENTAL

Telmisartan 80mg

Intervention Type DRUG

Rosuvastatin 20mg

Intervention Type DRUG

Placebo(for Rosuvastatin 10mg)

Intervention Type DRUG

Telmisartan 80mg & Rosuvastatin 10mg

PO, Once Daily, 8weeks

Group Type EXPERIMENTAL

Telmisartan 80mg

Intervention Type DRUG

Rosuvastatin 10mg

Intervention Type DRUG

Placebo(for Rosuvastatin 20mg)

Intervention Type DRUG

Telmisartan placebo & Rosuvastatin 20mg

PO, Once Daily, 8 weeks

Group Type ACTIVE_COMPARATOR

Rosuvastatin 20mg

Intervention Type DRUG

Placebo(for Telmisartan 80mg)

Intervention Type DRUG

Placebo(for Rosuvastatin 10mg)

Intervention Type DRUG

Telmisartan Placebo & Rosuvastatin 10mg

PO, Once Daily, 8 weeks

Group Type ACTIVE_COMPARATOR

Rosuvastatin 10mg

Intervention Type DRUG

Placebo(for Telmisartan 80mg)

Intervention Type DRUG

Placebo(for Rosuvastatin 20mg)

Intervention Type DRUG

Telmisartan 80mg & Rosuvastatin placebo

PO, Once Daily, 8 weeks

Group Type ACTIVE_COMPARATOR

Telmisartan 80mg

Intervention Type DRUG

Placebo(for Telmisartan 80mg)

Intervention Type DRUG

Placebo(for Rosuvastatin 20mg)

Intervention Type DRUG

Telmisartan placebo & Rosuvastatin placebo

PO, Once Daily, 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo(for Telmisartan 80mg)

Intervention Type DRUG

Placebo(for Rosuvastatin 20mg)

Intervention Type DRUG

Placebo(for Rosuvastatin 10mg)

Intervention Type DRUG

Interventions

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Telmisartan 80mg

Intervention Type DRUG

Rosuvastatin 20mg

Intervention Type DRUG

Rosuvastatin 10mg

Intervention Type DRUG

Placebo(for Telmisartan 80mg)

Intervention Type DRUG

Placebo(for Rosuvastatin 20mg)

Intervention Type DRUG

Placebo(for Rosuvastatin 10mg)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Catholic University of Saint Mary's Hosiptal

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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wook-seong chung, MD

Role: primary

Other Identifiers

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ID_Telotan_1203

Identifier Type: -

Identifier Source: org_study_id

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