UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000005170
Receipt number	R000006135
Scientific Title	Effect of a standard dose of telmisartan combined with amlodipine and trichlormethiazide versus a high dose of telmisartan combined with trichlormethiazide on urinary excretion of albumin in hypertensive patients with type 2 diabetes mellitus
Date of disclosure of the study information	2011/03/02
Last modified on	2012/03/02 17:41:02

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Basic information

Public title

Effect of a standard dose of telmisartan combined with amlodipine and trichlormethiazide versus a high dose of telmisartan combined with trichlormethiazide on urinary excretion of albumin in hypertensive patients with type 2 diabetes mellitus

Acronym

Effect of a Standard dose of Telmisartan combIned with aMlodipine and trichlormethiazide versus a high dose of telmisArtan combined with Trichlormethiazide on urinary Excretion of Albumin in hypertensive patients with type 2 diabetes mellitus (ESTIMATE-A)

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Type 2 diabetic patients with essential hypertension and albuminuria

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Nephrology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Strict blood pressure (BP) control as well as medication with renin-angiotensin system (RAS) inhibitors is essential to reduce and prevent the progression of albuminuria. However, effective BP control is particularly difficult to achieve in patients with diabetes mellitus and target BP levels are seldom achieved with standard doses of RAS inhibitors. Although calcium channel blockers are frequently used in combination with RAS inhibitors, the GUARD study demonstrated that benazepril combined with hydrochlorothiazide is superior to benazepril combined with amlodipine in reducing urinary excretion of albumin. However, combined treatment with a RAS inhibitor and a diuretic often fails to achieve target BP levels and enough reduction of urinary albumin. Thus, the present study is designed to investigate whether up-titrating the dose of telmisartan would be superior to adding amlodipine with respect to urinary albumin excretion for the same degree of BP reduction in diabetic patients with albuminuria being treated with a standard dose of telmisartan plus trichlormethiazide.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Changes in urinary excretion of albumin

Key secondary outcomes

Office BP, home BP, serum creatinine, serum uric acid, HbA1c, 24-h ABPM

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

ESTIMATE-A is a 6-months, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and albminuria are recruited and antihypertensive medications are either started on or switched to telmisartan (40mg/day) + trichlormethiazide (1mg/day). After a 3-month run-in period, baseline evaluations are performed and patients with BP >=130/80mmHg and urinary excretion of albumin >=30mg/g creatinine are enrolled. Then, patients are assigned to receive telmisartan (40mg/day) + amlodipine (5mg/day) + trichlormethiazide (1mg/day) for 6 months. In cases that the target blood pressure level (<130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level. Primary and secondary endpoints are evaluated at 3 and 6 months.

Interventions/Control_2

After a 3-month run-in period, baseline evaluations are performed and patients with BP >=130/80mmHg and urinary excretion of albumin >=30mg/g creatinine are enrolled. Then, patients are assigned to receive telmisartan (80mg/day) + trichlormethiazide (1mg/day) for 6 months. In cases that the target blood pressure level (<130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level. Primary and secondary endpoints are evaluated at 3 and 6 months.

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

Type 2 diabetic patients with essential hypertension and albuminuria are recruited and are either started on or switched to telmisartan (40mg/day) + trichlormethiazide (1mg/day) for 3 months (run-in -period). Patients aged 20 years or older with BP >=130/80 mmHg and urinary excretion of albumin >=30mg/g creatinine at the end of run-in-period are finally enrolled.

Key exclusion criteria

Previous acute coronary syndrome, myocardial infarction, or stroke <6 months before informed consent; serum creatinine >1.5mg/dL (male) and >1.2mg/dL (female); serum potassium >=5.5mEq/L; office BP >=180/110mmHg; uncontrolled diabetes mellitus (HbA1c >=9.0%).

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Masayoshi Kojima

Organization

Komono Kosei Hospital

Division name

Department of Internal Medicine

Zip code

Address

75 Hukumura, Komono-cho, Mie, Japan

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Cardio-Renal Medicine and Hypertension

Zip code

Address

TEL

Homepage URL

Email

ydohi@med.nagoya-cu.ac.jp

Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

Funding Source

Organization

none

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

菰野厚生病院（三重県）

Other administrative information

Date of disclosure of the study information

2011 Year 03 Month 02 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

2010 Year 11 Month 01 Day

Date of IRB

Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date

2012 Year 02 Month 01 Day

Date of closure to data entry

2012 Year 02 Month 01 Day

Date trial data considered complete

2012 Year 02 Month 01 Day

Date analysis concluded

2012 Year 02 Month 01 Day

Other

Other related information

Management information

Registered date

2011 Year 03 Month 02 Day

Last modified on

2012 Year 03 Month 02 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006135

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Medicine in general	Cardiology	Endocrinology and Metabolism
Nephrology