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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02087540

Enrollment

310

Registered

2014-03-14

Start date

2013-05-31

Completion date

Unknown

Last updated

2014-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Hyperlipidemia

Brief summary

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

Interventions

DRUGTelmisartan 80mg

DRUGRosuvastatin 20mg

DRUGRosuvastatin 10mg

DRUGPlacebo(for Telmisartan 80mg)

DRUGPlacebo(for Rosuvastatin 20mg)

DRUGPlacebo(for Rosuvastatin 10mg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

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

Design outcomes

Primary

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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026