Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

NCT ID: NCT00281580

Last Updated: 2014-03-27

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

1461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Placebo

Placebo once daily for eight weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to Telmisartan and Amlodipine once daily for eight weeks

Telmisartan 20 mg

Telmisartan 20 mg once daily for eight weeks

Group Type EXPERIMENTAL

Telmisartan 20 mg

Intervention Type DRUG

Telmisartan 20 mg once daily for eight weeks

Telmisartan 40 mg

Telmisartan 40 mg once daily for eight weeks

Group Type EXPERIMENTAL

Telmisartan 40 mg

Intervention Type DRUG

Telmisartan 40 mg once daily for eight weeks

Telmisartan 80 mg

Telmisartan 80 mg once daily for eight weeks

Group Type EXPERIMENTAL

Telmisartan 80 mg

Intervention Type DRUG

Telmisartan 80 mg once daily for eight weeks

Amlodipine 2.5 mg

Amlodipine 2.5 mg once daily for eight weeks

Group Type EXPERIMENTAL

Amlodipine 2.5 mg

Intervention Type DRUG

Amlodipine 2.5 mg once daily for eight weeks

Amlodipine 5 mg

Amlodipine 5 mg once daily for eight weeks

Group Type EXPERIMENTAL

Amlodipine 5 mg

Intervention Type DRUG

amlodipine 5g once daily for eight weeks

Amlodipine 10 mg

Amlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily

Group Type ACTIVE_COMPARATOR

Amlodipine 5 mg

Intervention Type DRUG

amlodipine 5g once daily for two weeks

Amlodipine 10 mg

Intervention Type DRUG

Amlodipine 10 mg once daily for six weeks

Telmisartan 20 / Amlodipine 2.5

Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks

Group Type EXPERIMENTAL

Telmisartan 20 mg

Intervention Type DRUG

Telmisartan 20 mg once daily for eight weeks

Amlodipine 2.5 mg

Intervention Type DRUG

Amlodipine 2.5 mg once daily for eight weeks

Telmisartan 20 / Amlodipine 5

Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks

Group Type EXPERIMENTAL

Telmisartan 20 mg

Intervention Type DRUG

Telmisartan 20 mg once daily for eight weeks

Amlodipine 5 mg

Intervention Type DRUG

amlodipine 5mg once daily for eight weeks

Telmisartan 20 / Amlodipine 10

Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

Group Type EXPERIMENTAL

Amlodipine 10 mg

Intervention Type DRUG

Amlodipine 10 mg once daily for six weeks

Telmisartan 20 mg

Intervention Type DRUG

Telmisartan 20 mg once daily for eight weeks

Amlodipine 5 mg

Intervention Type DRUG

Amlodipine 5 mg once daily for two weeks

Telmisartan 40 / Amlodipine 2.5

Telmisartan 40 / Amlodipine 2.5 for eight weeks

Group Type EXPERIMENTAL

Amlodipine 2.5 mg

Intervention Type DRUG

Amlodipine 2.5 mg once daily for eight weeks

Telmisartan 40 mg

Intervention Type DRUG

Telmisartan 40 mg once daily for eight weeks

Telmisartan 40 / Amlodipine 5

Telmisartan 40 / Amlodipine 5 for eight weeks

Group Type EXPERIMENTAL

Amlodipine 5 mg

Intervention Type DRUG

Amlodipine 5 mg once daily for eight weeks

Telmisartan 40 mg

Intervention Type DRUG

Telmisartan 40 mg once daily for eight weeks

Telmisartan 40 / Amlodipine 10

Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

Group Type EXPERIMENTAL

Telmisartan 40 mg

Intervention Type DRUG

Telmisartan 40 mg once daily for eight weeks

Amlodipine 10 mg

Intervention Type DRUG

Amlodipine 10 mg once daily for six weeks

Amlodipine 5 mg

Intervention Type DRUG

Amlodipine 5 mg once daily for two weeks

Telmisartan 80 / Amlodipine 2.5

Telmisartan 80 / Amlodipine 2.5 for eight weeks

Group Type EXPERIMENTAL

Amlodipine 2.5 mg

Intervention Type DRUG

Amlodipine 2.5 mg once daily for eight weeks

Telmisartan 80 mg

Intervention Type DRUG

Telmisartan 80 mg once daily for eight weeks

Telmisartan 80 / Amlodipine 5

Telmisartan 80 / Amlodipine 5 mg for eight weeks

Group Type EXPERIMENTAL

Telmisartan 80 mg

Intervention Type DRUG

Telmisartan 80 mg once daily for eight weeks

Amlodipine 5 mg

Intervention Type DRUG

Amlodipine 5 mg once daily for eight weeks

Telmisartan 80 / Amlodipine 10

Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

Group Type EXPERIMENTAL

Amlodipine 5 mg

Intervention Type DRUG

Amlodipine 5 mg once daily for two weeks

Telmisartan 80 mg

Intervention Type DRUG

Telmisartan 80 mg once daily for eight weeks

Amlodipine 10 mg

Intervention Type DRUG

Amlodipine 10 mg once daily for six weeks

Interventions

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Amlodipine 5 mg

Amlodipine 5 mg once daily for two weeks

Intervention Type DRUG

Placebo

Placebo to Telmisartan and Amlodipine once daily for eight weeks

Intervention Type DRUG

Telmisartan 20 mg

Telmisartan 20 mg once daily for eight weeks

Intervention Type DRUG

Telmisartan 40 mg

Telmisartan 40 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 10 mg

Amlodipine 10 mg once daily for six weeks

Intervention Type DRUG

Telmisartan 20 mg

Telmisartan 20 mg once daily for eight weeks

Intervention Type DRUG

Telmisartan 80 mg

Telmisartan 80 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 10 mg

Amlodipine 10 mg once daily for six weeks

Intervention Type DRUG

Telmisartan 20 mg

Telmisartan 20 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 5 mg

Amlodipine 5 mg once daily for two weeks

Intervention Type DRUG

Amlodipine 5 mg

amlodipine 5g once daily for eight weeks

Intervention Type DRUG

Telmisartan 20 mg

Telmisartan 20 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 5 mg

Amlodipine 5 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 5 mg

amlodipine 5mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 2.5 mg

Amlodipine 2.5 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 2.5 mg

Amlodipine 2.5 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 10 mg

Amlodipine 10 mg once daily for six weeks

Intervention Type DRUG

Amlodipine 2.5 mg

Amlodipine 2.5 mg once daily for eight weeks

Intervention Type DRUG

Telmisartan 80 mg

Telmisartan 80 mg once daily for eight weeks

Intervention Type DRUG

Telmisartan 80 mg

Telmisartan 80 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 5 mg

Amlodipine 5 mg once daily for two weeks

Intervention Type DRUG

Amlodipine 2.5 mg

Amlodipine 2.5 mg once daily for eight weeks

Intervention Type DRUG

Telmisartan 40 mg

Telmisartan 40 mg once daily for eight weeks

Intervention Type DRUG

Telmisartan 40 mg

Telmisartan 40 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 5 mg

amlodipine 5g once daily for two weeks

Intervention Type DRUG

Amlodipine 5 mg

Amlodipine 5 mg once daily for eight weeks

Intervention Type DRUG

Telmisartan 40 mg

Telmisartan 40 mg once daily for eight weeks

Intervention Type DRUG

Telmisartan 80 mg

Telmisartan 80 mg once daily for eight weeks

Intervention Type DRUG

Amlodipine 10 mg

Amlodipine 10 mg once daily for six weeks

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

1. Patient is pregnant; breast-feeding; unwilling to use birth control during the study; has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke within the last six months; myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months; unstable or uncontrolled diabetes for the past three months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history of angioedema or hypersensitivity related to either study drug.
2. Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury (mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.
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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1235.1.457 Boehringer Ingelheim Investigational Site

Fairhope, Alabama, United States

Site Status

1235.1.368 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Site Status

1235.1.389 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

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1235.1.411 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

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1235.1.429 Boehringer Ingelheim Investigational Site

Chandler, Arizona, United States

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1235.1.420 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

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1235.1.391 Boehringer Ingelheim Investigational Site

Cudahy, California, United States

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1235.1.444 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

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1235.1.445 Boehringer Ingelheim Investigational Site

Encino, California, United States

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1235.1.357 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

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1235.1.465 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

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1235.1.441 Boehringer Ingelheim Investigational Site

Riverside, California, United States

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1235.1.409 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

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1235.1.406 Boehringer Ingelheim Investigational Site

San Diego, California, United States

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1235.1.414 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

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1235.1.383 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

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1235.1.395 Boehringer Ingelheim Investigational Site

Tustin, California, United States

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1235.1.453 Boehringer Ingelheim Investigational Site

Milford, Connecticut, United States

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1235.1.394 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

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1235.1.354 Boehringer Ingelheim Investigational Site

Cooper City, Florida, United States

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1235.1.451 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

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1235.1.372 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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1235.1.396 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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1235.1.390 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

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1235.1.430 Boehringer Ingelheim Investigational Site

Kissimmee, Florida, United States

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1235.1.351 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

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1235.1.398 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

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1235.1.405 Boehringer Ingelheim Investigational Site

Mirimar, Florida, United States

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1235.1.352 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

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1235.1.369 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

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1235.1.397 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

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1235.1.449 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

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1235.1.355 Boehringer Ingelheim Investigational Site

Rockledge, Florida, United States

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1235.1.407 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

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1235.1.380 Boehringer Ingelheim Investigational Site

Tucker, Georgia, United States

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1235.1.438 Boehringer Ingelheim Investigational Site

Gurnee, Illinois, United States

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1235.1.373 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

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1235.1.375 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

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1235.1.415 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

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1235.1.412 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

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1235.1.435 Boehringer Ingelheim Investigational Site

Arkansas City, Kansas, United States

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1235.1.379 Boehringer Ingelheim Investigational Site

Lenexa, Kansas, United States

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1235.1.421 Boehringer Ingelheim Investigational Site

Newtown, Kansas, United States

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1235.1.356 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

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1235.1.423 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

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1235.1.387 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

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1235.1.424 Boehringer Ingelheim Investigational Site

Bay City, Michigan, United States

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1235.1.385 Boehringer Ingelheim Investigational Site

Florissant, Missouri, United States

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1235.1.452 Boehringer Ingelheim Investigational Site

Florissant, Missouri, United States

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1235.1.365 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

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1235.1.431 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

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1235.1.454 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

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1235.1.426 Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

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1235.1.434 Boehringer Ingelheim Investigational Site

Stratford, New Jersey, United States

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1235.1.366 Boehringer Ingelheim Investigational Site

East Syracuse, New York, United States

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1235.1.377 Boehringer Ingelheim Investigational Site

Northport, New York, United States

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1235.1.427 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

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1235.1.381 Boehringer Ingelheim Investigational Site

Williamsville, New York, United States

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1235.1.410 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

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1235.1.400 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

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1235.1.422 Boehringer Ingelheim Investigational Site

Greenboro, North Carolina, United States

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1235.1.403 Boehringer Ingelheim Investigational Site

Lenior, North Carolina, United States

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1235.1.376 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

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1235.1.392 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

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1235.1.384 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

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1235.1.458 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

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1235.1.374 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

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1235.1.446 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

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1235.1.413 Boehringer Ingelheim Investigational Site

Marion, Ohio, United States

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1235.1.359 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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1235.1.361 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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1235.1.436 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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1235.1.448 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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1235.1.386 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

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1235.1.439 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

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1235.1.440 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

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1235.1.408 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

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1235.1.404 Boehringer Ingelheim Investigational Site

Lansdale, Pennsylvania, United States

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1235.1.428 Boehringer Ingelheim Investigational Site

Penndel, Pennsylvania, United States

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1235.1.370 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

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1235.1.433 Boehringer Ingelheim Investigational Site

Beaufort, South Carolina, United States

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1235.1.462 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

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1235.1.417 Boehringer Ingelheim Investigational Site

Cordova, Tennessee, United States

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1235.1.459 Boehringer Ingelheim Investigational Site

Jackson, Tennessee, United States

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1235.1.363 Boehringer Ingelheim Investigational Site

New Tazewell, Tennessee, United States

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1235.1.382 Boehringer Ingelheim Investigational Site

Selmer, Tennessee, United States

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1235.1.442 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

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1235.1.399 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

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1235.1.460 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1235.1.443 Boehringer Ingelheim Investigational Site

Georgetown, Texas, United States

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1235.1.416 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

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1235.1.402 Boehringer Ingelheim Investigational Site

Lake Jackson, Texas, United States

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1235.1.432 Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

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1235.1.456 Boehringer Ingelheim Investigational Site

Odessa, Texas, United States

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1235.1.418 Boehringer Ingelheim Investigational Site

Plano, Texas, United States

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1235.1.455 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

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1235.1.358 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

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1235.1.464 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

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1235.1.437 Boehringer Ingelheim Investigational Site

Burke, Virginia, United States

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1235.1.447 Boehringer Ingelheim Investigational Site

Fredericksburg, Virginia, United States

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1235.1.371 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

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1235.1.001 Boehringer Ingelheim Investigational Site

BsAs, , Argentina

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1235.1.004 Boehringer Ingelheim Investigational Site

Buenos Aires, , Argentina

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1235.1.005 Boehringer Ingelheim Investigational Site

Buenos Aires, , Argentina

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1235.1.006 Boehringer Ingelheim Investigational Site

Buenos Aires, , Argentina

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1235.1.002 Boehringer Ingelheim Investigational Site

Carlos Paz, , Argentina

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1235.1.003 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

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1235.1.115 Universidade Federal do Pará

Belém, , Brazil

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1235.1.102 Liga de Hipertensão Arterial

Goiânia, , Brazil

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1235.1.101 Clínica Médica

Rio de Janeiro, , Brazil

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1235.1.103 Unidade de Hipertensão - ICHC -

São Paulo, , Brazil

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1235.1.109 Centro de Pesquisas do Hospital do Rim e Hipertensão

São Paulo, , Brazil

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1235.1.203

Col. Magdalena de Las Salinas, , Mexico

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1235.1.210 Consultorio Privado

Durango, Durango, , Mexico

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1235.1.202

Guadalajara, Jalisco, , Mexico

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1235.1.209 Boehringer Ingelheim Investigational Site

Guadalajara, Jalisco, , Mexico

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1235.1.204

Lomas de Guevara, Guadalajara, , Mexico

Site Status

1235.1.208 "Ignacio Chávez"

Mexico City, , Mexico

Site Status

1235.1.211 Obesidad Y Prevencion de Enfermedades

Mexico City, , Mexico

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1235.1.212 en Factores de riesgo cardiovascular

México, , Mexico

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1235.1.205 Fraccionamiento Industrias

San Luis Potosí City, , Mexico

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1235.1.207

Zapopan, Jalisco, , Mexico

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1235.1.314 Boehringer Ingelheim Investigational Site

Benoni, , South Africa

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1235.1.302 Boehringer Ingelheim Investigational Site

Boksburg, , South Africa

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1235.1.306 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1235.1.309 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1235.1.310 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1235.1.311 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1235.1.304 Boehringer Ingelheim Investigational Site

Durban, , South Africa

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1235.1.312 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1235.1.313 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1235.1.307 Boehringer Ingelheim Investigational Site

Krugersdorp, , South Africa

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1235.1.303 Boehringer Ingelheim Investigational Site

Lenasia, , South Africa

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1235.1.305 Boehringer Ingelheim Investigational Site

Lenasia, , South Africa

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1235.1.301 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Site Status

1235.1.308 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Site Status

Countries

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United States Argentina Brazil Mexico South Africa

Other Identifiers

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2008-000874-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1235.1

Identifier Type: -

Identifier Source: org_study_id

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