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An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

NCT ID: NCT01103960

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

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.

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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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Telmisartan80mg+Amlodipine5mg

combination therapy

Group Type EXPERIMENTAL

Telmisartan80mg+Amlodipine5mg

Intervention Type DRUG

combination therapy

amlodipine 5 mg

Monotherapy

Group Type ACTIVE_COMPARATOR

amlodipine 5mg

Intervention Type DRUG

monotherapy

Telmisartan80mg+Amlodipine 5mg

Intervention Type DRUG

combination therapy

Interventions

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Telmisartan80mg+Amlodipine5mg

combination therapy

Intervention Type DRUG

amlodipine 5mg

monotherapy

Intervention Type DRUG

Telmisartan80mg+Amlodipine 5mg

combination therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. diagnosis of essential hypertension
2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
3. provision of written informed consent

Exclusion Criteria

1\. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)
Minimum Eligible Age

18 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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1235.29.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1235.29.86004 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1235.29.86006 Boehringer Ingelheim Investigational Site

Changchun, , China

Site Status

1235.29.86013 Boehringer Ingelheim Investigational Site

Changsha, , China

Site Status

1235.29.86014 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1235.29.86012 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1235.29.86002 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1235.29.86009 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1235.29.86010 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1235.29.86011 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1235.29.86007 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1235.29.86008 Boehringer Ingelheim Investigational Site

Tianjin, , China

Site Status

1235.29.60017 Boehringer Ingelheim Investigational Site

Johor Bahru, , Malaysia

Site Status

1235.29.60016 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

Site Status

1235.29.63018 Boehringer Ingelheim Investigational Site

Metro Manila, , Philippines

Site Status

1235.29.63019 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

Countries

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China Malaysia Philippines

References

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Zhu D, Gao P, Holtbruegge W, Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014 Feb;42(1):52-66. doi: 10.1177/0300060513503756. Epub 2014 Jan 3.

Reference Type DERIVED
PMID: 24391142 (View on PubMed)

Other Identifiers

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1235.29

Identifier Type: -

Identifier Source: org_study_id

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