Trials Sponsors Conditions Drugs Pricing

Conditions

Essential Hypertension With Stable Angina and Dyslipidemia

Keywords

Pharmacotherapy

Outcome Measures

Primary Outcomes (1)

Change in percentage of the lipid pool in the coronary artery plaque
Change in percentage of the lipid pool in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32). Percentage of the lipid pool in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
32 weeks

Secondary Outcomes (5)

Change in volume of the coronary artery plaque
32 weeks
Change in percentage of the fibrotic component in the coronary artery plaque
32 weeks
Change in percentage of the calcified component in the coronary artery plaque
32 weeks
Change in number of microchannels
32 weeks
Change in thickness of the fibrous cap
32 weeks

Study Arms (1)

Azilsartan

EXPERIMENTAL

Azilsartan orally once daily in the morning, either before or after breakfast

Drug: Azilsartan

Interventions

AzilsartanDrug

Azilsartan tablets

Also known as: Azilva tablets

Azilsartan

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with essential hypertension with office blood pressure before the start of study treatment (Week 0) meeting the following criteria who are appropriate for azilsartan therapy in the opinion of the principal investigator or investigator
Patients aged ≥ 75 years at the time of informed consent: Sitting systolic blood pressure ≥ 150 mmHg or sitting diastolic blood pressure ≥ 90 mmHg

Sponsors & Collaborators

Takeda
Industrylead

Study Sites (1)

Tokushima, Japan

MeSH Terms

Conditions

Dyslipidemias

Interventions

azilsartan

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

General Manager
Takeda
STUDY DIRECTOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 27, 2015

Study Start

March 2015

Date type not reported

This date has not been verified as actual or estimated.

A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Azilsartan

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Azilsartan

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations