UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010895
Receipt number R000012749
Scientific Title The study for the efficacy of amlodipine/atorvastatin combination drug in patients with type 2 diabetes complicated with hypertention and hypercholestrolemia.
Date of disclosure of the study information 2013/06/08
Last modified on 2016/03/08 09:52:20

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Basic information

Public title

The study for the efficacy of amlodipine/atorvastatin combination drug in patients with type 2 diabetes complicated with hypertention and hypercholestrolemia.

Acronym

Caduet clinical research

Scientific Title

The study for the efficacy of amlodipine/atorvastatin combination drug in patients with type 2 diabetes complicated with hypertention and hypercholestrolemia.

Scientific Title:Acronym

Caduet clinical research

Region

Japan


Condition

Condition

Type 2 diabetes complicated with hypertention and hypercholestrolemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigatethe efficasy of amlodipine/atorvastatin combination drug in patients eith type 2 diabetes complicated with hypertentions and hypercholesterolemia,and which patients receive the treatment for hypertension with amolodipine besilate and do not achieve the lipid management goals,regardless with or without medication for hypercholesterolemia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)The amount of change in serum LDL-C levels between at baseline and after 6 months.
2)The amount of change in systolic blood pressure between at baseline and after 6 months.

Key secondary outcomes

1)The amount of change in serum LDL-C levels between at baseline and after 12 months.
2)The amount of change in systolic blood pressure between at baseline and after 12 months.
3)Achievement rate of lipid management goal of after 6 and 12 months.
4)The amount of change in the follwing items between at the baseline and 6 months or 12 months.
Diastolic blood pressure.
8-iso-PGF2 concentration in blood
The amount of change in oxidized LDL
Fasting blood glucose level
The amount of change in HbA1c
Cystatin-C concentration
Urinary albumin / creatinine ratio
eGFR
Blood adiponectin concentration
5)The amount of change in carotid IMT between at baseline and 6 or 12 months.
6)Adverse events.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switching to amlodipine / atorvastatin combination drug.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Outpatient
2) Patients receiving the treatment with amlodipine besilate for more than 3 months,at the time of registration.
3) Patients whose serum LDL-C levels are more than 120mg/dl,regardless with or without medication for hypercholesterolemia,at the time of registration.
4) Patients who can obtain voluntary conset documents for participation in this study,after a sufficient informed consent.

Key exclusion criteria

1) Patients whose systolic blood pressure is more than 180mmHg and diastolic blood pressure is more than 110mmHg and whose blood pressure are not well-controlled and considered to add or increase the dose of hypertensive drugs druing this study.
2) Secondry hypertention patiebs.
3) Familial hypercholesterolemia patients.
4) Patients with secondary prevention who developed cardiovascular events,such as acute myocardial infarction and cerebral infarction in the past.
5) Patients with severe heart failure patients.
6) Patients with severe arrhythmias.
7) eGFR is less than 40ml/min/1.73 square meters.
8) Patients with advanced liver failure.
9) Patients with active malignancy.
10)Patients during administration of immunosuppressants or steroid.
11) Women who are pregnant or possibly pregnant or wish to pregnant or lactating.
12)Patients with allergy or contraindication to test drug.
13) Intellectually or mentally disabled patients who are impossible to agree or with suspected ability to agree.
14) Patients judged not suitable by the attending physician.

Target sample size

240


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Koya

Organization

Kanazawa Medical University

Division name

Diabetes and Endocrinology

Zip code


Address

Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken

TEL

076-286-2211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Munehiro Kitada

Organization

Kanazawa Medical University

Division name

Diabetes and Endocrinology

Zip code


Address

Daigaku1-1 Uchinadamachi Kahokugun Ishikawaken

TEL

076-286-2211

Homepage URL


Email



Sponsor or person

Institute

Kanazawa Medical University
Diabetes and Endocrinology

Institute

Department

Personal name



Funding Source

Organization

Kanazawa Medical University
Diabetes and Endocrinology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 03 Month 11 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 07 Day

Last modified on

2016 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012749


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name