NCT02087540

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P50-P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

1.6 years

First QC Date

March 5, 2014

Last Update Submit

March 13, 2014

Conditions

HypertensionHyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • •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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (6)

Telmisartan 80mg & Rosuvastatin 20mg

EXPERIMENTAL

PO, Once Daily, 8 weeks

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

Telmisartan 80mg & Rosuvastatin 10mg

EXPERIMENTAL

PO, Once Daily, 8weeks

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

Telmisartan placebo & Rosuvastatin 20mg

ACTIVE COMPARATOR

PO, Once Daily, 8 weeks

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

Telmisartan Placebo & Rosuvastatin 10mg

ACTIVE COMPARATOR

PO, Once Daily, 8 weeks

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

Telmisartan 80mg & Rosuvastatin placebo

ACTIVE COMPARATOR

PO, Once Daily, 8 weeks

Drug: Telmisartan 80mgDrug: Placebo(for Telmisartan 80mg)Drug: Placebo(for Rosuvastatin 20mg)

Telmisartan placebo & Rosuvastatin placebo

PLACEBO COMPARATOR

PO, Once Daily, 8 weeks

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

Interventions

Telmisartan 80mgDRUG
Telmisartan 80mg & Rosuvastatin 10mgTelmisartan 80mg & Rosuvastatin 20mgTelmisartan 80mg & Rosuvastatin placebo
Rosuvastatin 20mgDRUG
Telmisartan 80mg & Rosuvastatin 20mgTelmisartan placebo & Rosuvastatin 20mg
Rosuvastatin 10mgDRUG
Telmisartan 80mg & Rosuvastatin 10mgTelmisartan Placebo & Rosuvastatin 10mg
Placebo(for Telmisartan 80mg)DRUG
Telmisartan 80mg & Rosuvastatin placeboTelmisartan Placebo & Rosuvastatin 10mgTelmisartan placebo & Rosuvastatin 20mgTelmisartan placebo & Rosuvastatin placebo
Placebo(for Rosuvastatin 20mg)DRUG
Telmisartan 80mg & Rosuvastatin 10mgTelmisartan 80mg & Rosuvastatin placeboTelmisartan Placebo & Rosuvastatin 10mgTelmisartan placebo & Rosuvastatin placebo
Placebo(for Rosuvastatin 10mg)DRUG
Telmisartan 80mg & Rosuvastatin 20mgTelmisartan placebo & Rosuvastatin 20mgTelmisartan placebo & Rosuvastatin placebo

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Saint Mary's Hosiptal

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

TelmisartanRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 14, 2014

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

KR(1)