NCT00281580

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,461

participants targeted

Target at P75+ for phase_3 hypertension

Geographic Reach
5 countries

136 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 28, 2010

Completed
Last Updated

March 27, 2014

Status Verified

February 1, 2014

Enrollment Period

11 months

First QC Date

January 24, 2006

Results QC Date

November 18, 2009

Last Update Submit

February 10, 2014

Conditions

Outcome Measures

Primary Outcomes (14)

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)

    Observed results

    Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)

    Observed results

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)

    Observed results

    End-of-study visit (LOCF)

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)

    Observed results

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)

    Observed results

    Up to 8 weeks (LOCF)

  • Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Up to 8 weeks (LOCF)

  • Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)

    Observed results

    Up to 8 weeks (LOCF)

  • Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Up to 8 weeks (LOCF)

  • Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)

    Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.

    Up to 8 weeks (LOCF)

Secondary Outcomes (28)

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP

    Baseline to end-of-study (up to 8 weeks) visit (LOCF)

  • DBP Control

    End-of-study (up to 8 weeks) visit (LOCF)

  • DBP Response

    End-of-study (up to 8 weeks) visit (LOCF)

  • +23 more secondary outcomes

Other Outcomes (4)

  • Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP

    Baseline to nominal week over the trial

  • BP Control

    End-of-study (up to 8 weeks) visit (LOCF)

  • Change From Baseline in Seated Trough Cuff DBP

    Nominal week over the trial

  • +1 more other outcomes

Study Arms (16)

Placebo

PLACEBO COMPARATOR

Placebo once daily for eight weeks

Drug: Placebo

Telmisartan 20 mg

EXPERIMENTAL

Telmisartan 20 mg once daily for eight weeks

Drug: Telmisartan 20 mg

Telmisartan 40 mg

EXPERIMENTAL

Telmisartan 40 mg once daily for eight weeks

Drug: Telmisartan 40 mg

Telmisartan 80 mg

EXPERIMENTAL

Telmisartan 80 mg once daily for eight weeks

Drug: Telmisartan 80 mg

Amlodipine 2.5 mg

EXPERIMENTAL

Amlodipine 2.5 mg once daily for eight weeks

Drug: Amlodipine 2.5 mg

Amlodipine 5 mg

EXPERIMENTAL

Amlodipine 5 mg once daily for eight weeks

Drug: Amlodipine 5 mg

Amlodipine 10 mg

ACTIVE COMPARATOR

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

Drug: Amlodipine 5 mgDrug: Amlodipine 10 mg

Telmisartan 20 / Amlodipine 2.5

EXPERIMENTAL

Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks

Drug: Telmisartan 20 mgDrug: Amlodipine 2.5 mg

Telmisartan 20 / Amlodipine 5

EXPERIMENTAL

Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks

Drug: Telmisartan 20 mgDrug: Amlodipine 5 mg

Telmisartan 20 / Amlodipine 10

EXPERIMENTAL

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

Drug: Amlodipine 10 mgDrug: Telmisartan 20 mgDrug: Amlodipine 5 mg

Telmisartan 40 / Amlodipine 2.5

EXPERIMENTAL

Telmisartan 40 / Amlodipine 2.5 for eight weeks

Drug: Amlodipine 2.5 mgDrug: Telmisartan 40 mg

Telmisartan 40 / Amlodipine 5

EXPERIMENTAL

Telmisartan 40 / Amlodipine 5 for eight weeks

Drug: Amlodipine 5 mgDrug: Telmisartan 40 mg

Telmisartan 40 / Amlodipine 10

EXPERIMENTAL

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

Drug: Telmisartan 40 mgDrug: Amlodipine 10 mgDrug: Amlodipine 5 mg

Telmisartan 80 / Amlodipine 2.5

EXPERIMENTAL

Telmisartan 80 / Amlodipine 2.5 for eight weeks

Drug: Amlodipine 2.5 mgDrug: Telmisartan 80 mg

Telmisartan 80 / Amlodipine 5

EXPERIMENTAL

Telmisartan 80 / Amlodipine 5 mg for eight weeks

Drug: Telmisartan 80 mgDrug: Amlodipine 5 mg

Telmisartan 80 / Amlodipine 10

EXPERIMENTAL

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

Drug: Amlodipine 5 mgDrug: Telmisartan 80 mgDrug: Amlodipine 10 mg

Interventions

Amlodipine 5 mg once daily for two weeks

Telmisartan 80 / Amlodipine 10

Placebo to Telmisartan and Amlodipine once daily for eight weeks

Placebo

Telmisartan 20 mg once daily for eight weeks

Telmisartan 20 mg

Telmisartan 40 mg once daily for eight weeks

Telmisartan 40 / Amlodipine 10

Amlodipine 10 mg once daily for six weeks

Telmisartan 20 / Amlodipine 10

Telmisartan 80 mg once daily for eight weeks

Telmisartan 80 / Amlodipine 10

Amlodipine 2.5 mg once daily for eight weeks

Amlodipine 2.5 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (136)

1235.1.457 Boehringer Ingelheim Investigational Site

Fairhope, Alabama, United States

Location

1235.1.368 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

1235.1.389 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

1235.1.411 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

1235.1.429 Boehringer Ingelheim Investigational Site

Chandler, Arizona, United States

Location

1235.1.420 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Location

1235.1.391 Boehringer Ingelheim Investigational Site

Cudahy, California, United States

Location

1235.1.444 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Location

1235.1.445 Boehringer Ingelheim Investigational Site

Encino, California, United States

Location

1235.1.357 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1235.1.465 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1235.1.441 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Location

1235.1.409 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

1235.1.406 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1235.1.414 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Location

1235.1.383 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Location

1235.1.395 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Location

1235.1.453 Boehringer Ingelheim Investigational Site

Milford, Connecticut, United States

Location

1235.1.394 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Location

1235.1.354 Boehringer Ingelheim Investigational Site

Cooper City, Florida, United States

Location

1235.1.451 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1235.1.372 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1235.1.396 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1235.1.390 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Location

1235.1.430 Boehringer Ingelheim Investigational Site

Kissimmee, Florida, United States

Location

1235.1.351 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

Location

1235.1.398 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

Location

1235.1.405 Boehringer Ingelheim Investigational Site

Mirimar, Florida, United States

Location

1235.1.352 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1235.1.369 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1235.1.397 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1235.1.449 Boehringer Ingelheim Investigational Site

Pensacola, Florida, United States

Location

1235.1.355 Boehringer Ingelheim Investigational Site

Rockledge, Florida, United States

Location

1235.1.407 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1235.1.380 Boehringer Ingelheim Investigational Site

Tucker, Georgia, United States

Location

1235.1.438 Boehringer Ingelheim Investigational Site

Gurnee, Illinois, United States

Location

1235.1.373 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

1235.1.375 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

1235.1.415 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

1235.1.412 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Location

1235.1.435 Boehringer Ingelheim Investigational Site

Arkansas City, Kansas, United States

Location

1235.1.379 Boehringer Ingelheim Investigational Site

Lenexa, Kansas, United States

Location

1235.1.421 Boehringer Ingelheim Investigational Site

Newtown, Kansas, United States

Location

1235.1.356 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

1235.1.423 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

1235.1.387 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1235.1.424 Boehringer Ingelheim Investigational Site

Bay City, Michigan, United States

Location

1235.1.385 Boehringer Ingelheim Investigational Site

Florissant, Missouri, United States

Location

1235.1.452 Boehringer Ingelheim Investigational Site

Florissant, Missouri, United States

Location

1235.1.365 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1235.1.431 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1235.1.454 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

Location

1235.1.426 Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

Location

1235.1.434 Boehringer Ingelheim Investigational Site

Stratford, New Jersey, United States

Location

1235.1.366 Boehringer Ingelheim Investigational Site

East Syracuse, New York, United States

Location

1235.1.377 Boehringer Ingelheim Investigational Site

Northport, New York, United States

Location

1235.1.427 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

1235.1.381 Boehringer Ingelheim Investigational Site

Williamsville, New York, United States

Location

1235.1.410 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Location

1235.1.400 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1235.1.422 Boehringer Ingelheim Investigational Site

Greenboro, North Carolina, United States

Location

1235.1.403 Boehringer Ingelheim Investigational Site

Lenior, North Carolina, United States

Location

1235.1.376 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1235.1.392 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1235.1.384 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1235.1.458 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1235.1.374 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1235.1.446 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1235.1.413 Boehringer Ingelheim Investigational Site

Marion, Ohio, United States

Location

1235.1.359 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1235.1.361 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1235.1.436 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1235.1.448 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1235.1.386 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

1235.1.439 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1235.1.440 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1235.1.408 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

Location

1235.1.404 Boehringer Ingelheim Investigational Site

Lansdale, Pennsylvania, United States

Location

1235.1.428 Boehringer Ingelheim Investigational Site

Penndel, Pennsylvania, United States

Location

1235.1.370 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Location

1235.1.433 Boehringer Ingelheim Investigational Site

Beaufort, South Carolina, United States

Location

1235.1.462 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

1235.1.417 Boehringer Ingelheim Investigational Site

Cordova, Tennessee, United States

Location

1235.1.459 Boehringer Ingelheim Investigational Site

Jackson, Tennessee, United States

Location

1235.1.363 Boehringer Ingelheim Investigational Site

New Tazewell, Tennessee, United States

Location

1235.1.382 Boehringer Ingelheim Investigational Site

Selmer, Tennessee, United States

Location

1235.1.442 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1235.1.399 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

Location

1235.1.460 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1235.1.443 Boehringer Ingelheim Investigational Site

Georgetown, Texas, United States

Location

1235.1.416 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1235.1.402 Boehringer Ingelheim Investigational Site

Lake Jackson, Texas, United States

Location

1235.1.432 Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

Location

1235.1.456 Boehringer Ingelheim Investigational Site

Odessa, Texas, United States

Location

1235.1.418 Boehringer Ingelheim Investigational Site

Plano, Texas, United States

Location

1235.1.455 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

Location

1235.1.358 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1235.1.464 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1235.1.437 Boehringer Ingelheim Investigational Site

Burke, Virginia, United States

Location

1235.1.447 Boehringer Ingelheim Investigational Site

Fredericksburg, Virginia, United States

Location

1235.1.371 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1235.1.001 Boehringer Ingelheim Investigational Site

BsAs, Argentina

Location

1235.1.004 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

Location

1235.1.005 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

Location

1235.1.006 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

Location

1235.1.002 Boehringer Ingelheim Investigational Site

Carlos Paz, Argentina

Location

1235.1.003 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

Location

1235.1.115 Universidade Federal do Pará

Belém, Brazil

Location

1235.1.102 Liga de Hipertensão Arterial

Goiânia, Brazil

Location

1235.1.101 Clínica Médica

Rio de Janeiro, Brazil

Location

1235.1.103 Unidade de Hipertensão - ICHC -

São Paulo, Brazil

Location

1235.1.109 Centro de Pesquisas do Hospital do Rim e Hipertensão

São Paulo, Brazil

Location

1235.1.203

Col. Magdalena de Las Salinas, Mexico

Location

1235.1.210 Consultorio Privado

Durango, Durango, Mexico

Location

1235.1.202

Guadalajara, Jalisco, Mexico

Location

1235.1.209 Boehringer Ingelheim Investigational Site

Guadalajara, Jalisco, Mexico

Location

1235.1.204

Lomas de Guevara, Guadalajara, Mexico

Location

1235.1.208 "Ignacio Chávez"

Mexico City, Mexico

Location

1235.1.211 Obesidad Y Prevencion de Enfermedades

Mexico City, Mexico

Location

1235.1.212 en Factores de riesgo cardiovascular

México, Mexico

Location

1235.1.205 Fraccionamiento Industrias

San Luis Potosí City, Mexico

Location

1235.1.207

Zapopan, Jalisco, Mexico

Location

1235.1.314 Boehringer Ingelheim Investigational Site

Benoni, South Africa

Location

1235.1.302 Boehringer Ingelheim Investigational Site

Boksburg, South Africa

Location

1235.1.306 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.1.309 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.1.310 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.1.311 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.1.304 Boehringer Ingelheim Investigational Site

Durban, South Africa

Location

1235.1.312 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1235.1.313 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1235.1.307 Boehringer Ingelheim Investigational Site

Krugersdorp, South Africa

Location

1235.1.303 Boehringer Ingelheim Investigational Site

Lenasia, South Africa

Location

1235.1.305 Boehringer Ingelheim Investigational Site

Lenasia, South Africa

Location

1235.1.301 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

1235.1.308 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

MeSH Terms

Conditions

Hypertension

Interventions

AmlodipineTelmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 25, 2006

Study Start

April 1, 2006

Primary Completion

March 1, 2007

Last Updated

March 27, 2014

Results First Posted

April 28, 2010

Record last verified: 2014-02

Locations