UMIN-CTR Clinical Trial

Public title

Effect of Combination tablets with telmisartan and amlodipine in hypertensive patients with metabolic syndrome not controlled by conventional therapy, randomized, open label, multicenter, parallel group study

Acronym

Effect of Combination tablets with telmisartan and amlodipine in hypertensive patients with metabolic syndrome (Cotalo)

Scientific Title

Effect of Combination tablets with telmisartan and amlodipine in hypertensive patients with metabolic syndrome not controlled by conventional therapy, randomized, open label, multicenter, parallel group study

Scientific Title:Acronym

Effect of Combination tablets with telmisartan and amlodipine in hypertensive patients with metabolic syndrome (Cotalo)

Region

Japan

Condition

Hypertension with metabolic syndrome

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the antihypertensive effect and effects on sympathetic nerve system and metabolic parameters of Micamlo Combination tablets morning dosing/evening dosing in hypertensive patients complicated with metabolic syndrome who were not controlled by amlodipine 5 mg/day.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes of 24hr blood pressure on ABPM(24hr, daytime, nocturnal, early morning)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral administration of Micamlo combination Tablets AP (telmisartan 40 mg/day + amlodipine 5 mg/day) in the morning

Interventions/Control_2

Oral administration of Micamlo combination Tablets AP (telmisartan 40 mg/day + amlodipine 5 mg/day) in the evening

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

30

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Ambulant patients, regardless of sex.
Age is over 30 years old.
Patients with uncontrolled hypertension by amlodipine 5 mg/day complicated with metabolic syndrome.
Hypertension;
>= SBP 140mmHg and/or >= DBP 90mmHg
Metabolic syndrome;
waist size >=85cm in male, >= 90cm in female and have one or both symptoms listed below.
1. TG >= 150mg/dL and/or HDL >=40mg/dL
2. FPG >= 110mg/dL

Key exclusion criteria

1) Secondary hypertension
2) Severe hypertension with office systolic blood pressure over 180mmHg and/or diastolic blood pressure over 110mmHg
3) Malignant hypertension
4) Continuous ventricular tachycardia or severe arrythmia (AV block II-III, Af etc)
5) Severe heart failure (NYHA III-IV)
6) Myocardial Infarction, Coronary bypass surgery, and PTCA were performed within 6 months
7) Patients contraindicated for the use of amlodipine, telmisartan
8) Serum creatinine >2.1mg/dL
9) Hypersensitivity with telmisartan and amlodipine
10) Patients who are inadequate to entry this study judged by physicians in charge

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuru Ohishi

Organization

Osaka University

Division name

Department of Geriatric Medicine & Nephrology

Zip code

Address

Yamadaoka 2-2 B6, Suita-city Osaka-fu,

TEL

Email

Name of contact person

1st name
Middle name
Last name	Mitsuru Ohishi

Organization

Osaka University

Division name

Department of Geriatric Medicine & Nephrology

Zip code

Address

Yamadaoka 2-2 B6, Suita-city Osaka-fu,

TEL

06-6879-3852

Homepage URL

Email

Institute

Osaka University

Institute

Department

Personal name

Organization

Osaka University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

2011

Year

03

Month

18

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

Preinitiation

Date of protocol fixation

2011

Year

02

Month

24

Day

Date of IRB

Anticipated trial start date

2011

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

03

Month

17

Day

Last modified on

2011

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006102