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Add-on to Micamlo BP Trial

NCT ID: NCT01975246

Last Updated: 2016-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-07-31

Brief Summary

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This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Telmisartan+amlodipine+HCTZ

telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet

Group Type EXPERIMENTAL

Telmisartan + amlodipine

Intervention Type DRUG

FDC tablet

hydrochlorothiazide

Intervention Type DRUG

tablet

Telmisartan+amlodipine

telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet

Group Type ACTIVE_COMPARATOR

Telmisartan + amlodipine

Intervention Type DRUG

FDC tablet

Placebo

Intervention Type DRUG

placebo matching hydrochlorothiazide tablet

Interventions

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Telmisartan + amlodipine

FDC tablet

Intervention Type DRUG

hydrochlorothiazide

tablet

Intervention Type DRUG

Telmisartan + amlodipine

FDC tablet

Intervention Type DRUG

Placebo

placebo matching hydrochlorothiazide tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be \>=90 and \<=114 mmHg and mean seated systolic blood pressure (SBP) must be =\<200 mmHg
* Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
* Age 20 years or older

Exclusion Criteria

* Patients with known or suspected secondary hypertension
* Patients with clinically relevant cardiac arrhythmia
* Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
* Patients with recent cardiovascular events
* Patients with recent stroke events
* Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
* Patients with hepatic and/or renal dysfunction
* Pre-menopausal women who are nursing or pregnant
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1348.1.015 Boehringer Ingelheim Investigational Site

Atsubetsu-ku,Sapporo,Hokkaido, , Japan

Site Status

1348.1.006 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, , Japan

Site Status

1348.1.002 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, , Japan

Site Status

1348.1.005 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, , Japan

Site Status

1348.1.031 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, , Japan

Site Status

1348.1.030 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1348.1.033 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1348.1.016 Boehringer Ingelheim Investigational Site

Chuo-ku,Sapporo,Hokkaido, , Japan

Site Status

1348.1.021 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, , Japan

Site Status

1348.1.024 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, , Japan

Site Status

1348.1.028 Boehringer Ingelheim Investigational Site

Itoshima, Fukuoka, , Japan

Site Status

1348.1.027 Boehringer Ingelheim Investigational Site

Katsushika-ku, Tokyo, , Japan

Site Status

1348.1.001 Boehringer Ingelheim Investigational Site

Kishiwada, Osaka, , Japan

Site Status

1348.1.009 Boehringer Ingelheim Investigational Site

Kita-ku, Osaka, , Japan

Site Status

1348.1.029 Boehringer Ingelheim Investigational Site

Kita-ku, Osaka, , Japan

Site Status

1348.1.014 Boehringer Ingelheim Investigational Site

Kiyose,Tokyo, , Japan

Site Status

1348.1.003 Boehringer Ingelheim Investigational Site

Koto-ku, Tokyo, , Japan

Site Status

1348.1.022 Boehringer Ingelheim Investigational Site

Mihama-ku, Chiba, Chiba, , Japan

Site Status

1348.1.004 Boehringer Ingelheim Investigational Site

Miyagino-ku, Sendai, Miyagi, , Japan

Site Status

1348.1.017 Boehringer Ingelheim Investigational Site

Moriya, Ibaraki, , Japan

Site Status

1348.1.013 Boehringer Ingelheim Investigational Site

Naka-ku,Yokohama,Kanagawa, , Japan

Site Status

1348.1.018 Boehringer Ingelheim Investigational Site

Nishi-ku, Fukuoka, Fukuoka, , Japan

Site Status

1348.1.007 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, , Japan

Site Status

1348.1.020 Boehringer Ingelheim Investigational Site

Sakaide, Kagawa, , Japan

Site Status

1348.1.025 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1348.1.026 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1348.1.008 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1348.1.032 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1348.1.019 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, , Japan

Site Status

1348.1.023 Boehringer Ingelheim Investigational Site

Toshima-ku, Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1348.1

Identifier Type: -

Identifier Source: org_study_id