UMIN-CTR Clinical Trial

Public title

Effectiveness of Switch to Combination Drug on Adherence among Patients with Dyslipidemia and Hypertension

Acronym

ESCAPADE trial

Scientific Title

Effectiveness of Switch to Combination Drug on Adherence among Patients with Dyslipidemia and Hypertension

Scientific Title:Acronym

ESCAPADE trial

Region

Japan

Condition

Patients with Dyslipidemia and Hypertension

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the serum LDL Cholesterol value between the multiple drug strategy and the combination drug strategy among patients with dyslipidemia and hypertention who take both 10mg of atorvastatin and 5mg of amlodipine.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

the difference of the serum LDL Cholesterol value between groups

Key secondary outcomes

(1) Rate and amount of change in serum LDL-Cho value
(2) Quantitative analysis of drug adherence using Japanese edition of MMAS-8 questionnaire
(3) Rate and amount of change among other lipid profiles such as HDL-Cho, T-Cho, and TG
(4) Rate of achievement in the treatment goal according to the Japanese guideline for the prevention of atherosclerosis
(5) Rate and amount of change in office blood pressures
(6) Subanalyses as to sex, age, BMI, serum LDL value on baseline, number of tablets taken, and use of narcotics
(7) Effect of the change in pattern to take drugs on serum lipid profiles

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Once daily intake of 1 tablet of combination drug of atorvastatin 10mg and amlodipine 5mg on the morning

Interventions/Control_2

Once daily intake of each 1 tablet of atorvastatin 10mg and amlodipine 5mg on the morning

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with dyslipidemia and hypertension who take both 10mg of atorvastatin and 5mg of amlodipine

Key exclusion criteria

(1) Patients who have a history of stroke or AMI within 3 months
(2) Patients with extremely unstable dyslipidemia or hypertension
(3) Patients who are joining (or have joined within 3 months) other clinical trials
(4) Patients who are taking drugs for dyslipidemia other than atorvastatin
(5) Patients whose serum Triglyceride value exceeds 400 mg/dL
(6) Patients with familial hyperlipidemia
(7) Patients with secondary hyperlipidemia
(8) Patients who are taking steroids
(9) Patients who are suspected to have drug-induced muscle injury
(10) Patients who have, suspected to have, or have a history of elective surgical therapy of malignancies within 3 years.
(11) Patients whose serum CK value exceeds threefold of the upper normal limit
(12) Patients who have contraindication to the statins or calcium-channel blockers, especially due to hypersensitivity or serious liver damage
(13) Patients who are (suspected to be) pregnant
(14) Patients who are considered unsuitable for the study by the responsible doctor for some reasonable causes.

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Sho Okada

Organization

Chiba University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-8-1, Inohana, Chuo-ku, Chiba, Japan

TEL

0432262555

Email

shookada_circ@chiba-u.jp

Name of contact person

1st name
Middle name
Last name	Sho Okada

Organization

Chiba University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-8-1, Inohana, Chuo-ku, Chiba, Japan

TEL

0432262555

Homepage URL

Email

shookada_circ@chiba-u.jp

Institute

Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

04

Month

15

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

01

Day

Last follow-up date

2014

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

05

Month

29

Day

Last modified on

2016

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012677