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An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

NCT ID: NCT00618774

Last Updated: 2014-06-27

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

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

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Detailed Description

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Conditions

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Hypertension

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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telmisartan40/amlodipine5

Intervention Type DRUG

telmisartan80/amlodipine5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with essential hypertension
2. Outpatient

Exclusion Criteria

* Patients whose SBP \>=180 mmHg or DBP \>=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
Minimum Eligible Age

20 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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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1235.16.004 Boehringer Ingelheim Investigational Site

Chofu, Tokyo, , Japan

Site Status

1235.16.006 Boehringer Ingelheim Investigational Site

Nishi-ku, Hiroshima, Hiroshima, , Japan

Site Status

1235.16.005 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1235.16.007 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1235.16.003 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

1235.16.001 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, , Japan

Site Status

1235.16.002 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1235.16

Identifier Type: -

Identifier Source: org_study_id

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