NCT03210532

Brief Summary

A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

October 7, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

October 12, 2016

Last Update Submit

January 30, 2018

Conditions

HypertensionDyslipidemia

Outcome Measures

Primary Outcomes (2)

  • Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline

    8-week

  • Change of LDL-C(Low Density Lipid Cholesterol) from baseline

    8-week

Study Arms (3)

Test

EXPERIMENTAL

qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)

Drug: Telmisartan + Amlodipine + Rosuvastatin

Reference 1

ACTIVE COMPARATOR

qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)

Drug: Telmisartan + Rosuvastatin

Reference 2

ACTIVE COMPARATOR

qd PO,Twynsta(telmisartan/amlodipine)

Drug: Telmisartan + Amlodipine

Interventions

Telmisartan + Amlodipine + RosuvastatinDRUG

Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo

Test
Telmisartan + AmlodipineDRUG

Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo

Reference 2
Telmisartan + RosuvastatinDRUG

Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo

Reference 1

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults both male and female who are ≥19,\<80 years old
  • at screening, 140mmHg≤ SBP\<180mmHg \& 90mmHg≤ DBP\<110mmHg \& LDL-C≤250mg/dL \& triglyceride\<400mg/dL

You may not qualify if:

  • at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
  • secondary hypertension or secondary dyslipidemia
  • patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
  • women who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevrance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

TelmisartanAmlodipineRosuvastatin Calciumtelmisartan amlodipine combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidines

Study Design

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

Study Record Dates

First Submitted

October 12, 2016

First Posted

July 7, 2017

Study Start

October 7, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

KR(1)