HypertensionPhase 3NCT00281593

Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension

A Phase 3 study testing Telmisartan and Ramipril in people with Hypertension, run by Boehringer Ingelheim at 119 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Telmisartan and Ramipril
How many people: 1,354 participants
Where: 119 sitesin 6 countries
Study dates: Apr 2006to Apr 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients >=18 years of age with Stage I or II hypertension defined as:
a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Who cannot join

Pregnant
breast-feeding
unwilling to use birth control during the study
secondary hypertension
SBP>=180 mmHg
DBP>=120 mmHg

Show all 12Show fewer

severe renal dysfunction
hepatic insufficiency
stroke within the last 6 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
history of angioedema of either of the study drugs, and hypersensitivity to the study drugs.

Trial locations and contacts

119 sites in 6 countries.

Country

City, postcode or hospital

119 sites in 6 countries

United States70 sites

1236.1.508 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1236.1.522 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1236.1.542 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1236.1.551 Boehringer Ingelheim Investigational Site
Auburn, Maine
1236.1.553 Boehringer Ingelheim Investigational Site
Avon, Indiana
1236.1.565 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia
1236.1.528 Boehringer Ingelheim Investigational Site
Boulder, Colorado
1236.1.523 Boehringer Ingelheim Investigational Site
Buena Park, California
1236.1.555 Boehringer Ingelheim Investigational Site
Cadillac, Michigan
1236.1.568 Boehringer Ingelheim Investigational Site
Carrollton, Texas
1236.1.547 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1236.1.567 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1236.1.514 Boehringer Ingelheim Investigational Site
Concord, California
1236.1.554 Boehringer Ingelheim Investigational Site
Corvallis, Oregon
1236.1.534 Boehringer Ingelheim Investigational Site
Cumberland, Rhode Island
1236.1.572 Boehringer Ingelheim Investigational Site
DeLand, Florida
1236.1.560 Boehringer Ingelheim Investigational Site
Encinitas, California
1236.1.569 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania
1236.1.524 Boehringer Ingelheim Investigational Site
Eugene, Oregon
1236.1.541 Boehringer Ingelheim Investigational Site
Excelsior Springs, Missouri
1236.1.502 Boehringer Ingelheim Investigational Site
Falls Church, Virginia
1236.1.530 Boehringer Ingelheim Investigational Site
Farmington, Connecticut
1236.1.511 Boehringer Ingelheim Investigational Site
Glendale, Arizona
1236.1.505 Ledeeach Family Medicine
Harleysville, Pennsylvania
1236.1.536 Boehringer Ingelheim Investigational Site
Haverhill, Massachusetts
1236.1.577 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1236.1.549 Boehringer Ingelheim Investigational Site
Houston, Texas
1236.1.559 Boehringer Ingelheim Investigational Site
Houston, Texas
1236.1.546 River Cities Cardiology Research Inst of Middle America
Jeffersonville, Indiana
1236.1.526 Boehringer Ingelheim Investigational Site
Jupiter, Florida
1236.1.515 Boehringer Ingelheim Investigational Site
Kettering, Ohio
1236.1.527 Boehringer Ingelheim Investigational Site
Largo, Florida
1236.1.556 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1236.1.573 Boehringer Ingelheim Investigational Site
Long Beach, California
1236.1.516 Boehringer Ingelheim Investigational Site
Los Angeles, California
1236.1.504 Boehringer Ingelheim Investigational Site
Madison, Wisconsin
1236.1.540 Boehringer Ingelheim Investigational Site
Madison, Wisconsin
1236.1.544 Boehringer Ingelheim Investigational Site
Medford, Oregon
1236.1.562 Boehringer Ingelheim Investigational Site
Menomonee Falls, Wisconsin
1236.1.538 Boehringer Ingelheim Investigational Site
Meridian, Idaho
1236.1.503 Anchor Research Center
Naples, Florida
1236.1.520 Boehringer Ingelheim Investigational Site
New Port Richey, Florida
1236.1.517 Boehringer Ingelheim Investigational Site
Newton, Kansas
1236.1.576 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1236.1.571 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1236.1.532 Boehringer Ingelheim Investigational Site
Peoria, Illinois
1236.1.545 Boehringer Ingelheim Investigational Site
Portland, Oregon
1236.1.566 Boehringer Ingelheim Investigational Site
Richmond, Kentucky
1236.1.529 Boehringer Ingelheim Investigational Site
Roseville, California
1236.1.510 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1236.1.513 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1236.1.521 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1236.1.548 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1236.1.550 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1236.1.512 Boehringer Ingelheim Investigational Site
Sandy City, Utah
1236.1.535 Boehringer Ingelheim Investigational Site
Sandy City, Utah
1236.1.539 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1236.1.574 Boehringer Ingelheim Investigational Site
Tempe, Arizona
1236.1.570 Boehringer Ingelheim Investigational Site
The Colony, Texas
1236.1.564 Boehringer Ingelheim Investigational Site
Tipton, Pennsylvania
1236.1.525 Physicians Research Center, LLC, Toms River
Toms River, New Jersey
1236.1.509 Boehringer Ingelheim Investigational Site
Troy, Michigan
1236.1.501 Boehringer Ingelheim Investigational Site
Tucson, Arizona
1236.1.557 Boehringer Ingelheim Investigational Site
Tucson, Arizona
1236.1.575 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
1236.1.519 Boehringer Ingelheim Investigational Site
Tustin, California
1236.1.563 Boehringer Ingelheim Investigational Site
Valparaiso, Indiana
1236.1.561 Clinical Research Center of Cape Cod
West Yarmouth, Massachusetts
1236.1.543 Boehringer Ingelheim Investigational Site
Westlake Village, California
1236.1.531 Boehringer Ingelheim Investigational Site
Wichita, Kansas

Other trials in United States

Argentina21 sites

1236.1.601 Boehringer Ingelheim Investigational Site
Buenos Aires
1236.1.604 Boehringer Ingelheim Investigational Site
Buenos Aires
1236.1.605 Boehringer Ingelheim Investigational Site
Buenos Aires
1236.1.610
Buenos Aires
1236.1.612
Buenos Aires
1236.1.608
Capital Federal
1236.1.618 Hospital Ramos Mejia
Capital Federal
1236.1.619
Capital Federal,Buenos Aires
1236.1.603 Boehringer Ingelheim Investigational Site
Córdoba
1236.1.606
Córdoba
1236.1.613
Córdoba
1236.1.614
Córdoba
1236.1.615
CordobaCordoba
1236.1.611
Corrientes
1236.1.624 Instituto de Investigaciones Clínicas
Mar del Plata
1236.1.609
Presidente Derqui
1236.1.620 DIM - Clinica Privada
Ramos Mejía
1236.1.622 Hospital San Bernardo
Salta
1236.1.621 Clinica del Torax y Especialidades
Santa Fe
1236.1.602 Boehringer Ingelheim Investigational Site
Villa Carlos Paz
1236.1.616
Zárate

Other trials in Argentina

Canada11 sites

1236.1.208 Shoppers Drug Mart Building
Bay Roberts, Newfoundland and Labrador
1236.1.202 North Road Medical Centre
Coquitlam, British Columbia
1236.1.203 MSHJ Research Associates
Halifax, Nova Scotia
1236.1.210 Hamilton Medical Research
Hamilton, Ontario
1236.1.204 Dr. Ivan Jagas
Kitchener, Ontario
1236.1.206 77 Commonwealth Avenue
Mount Pearl, Newfoundland and Labrador
1236.1.209 St. Joseph Cardiovascular Inc
Ottawa, Ontario
1236.1.205 Ctr. Hospital U Quebec- Pav CHUL
Sainte-Foy, Quebec
1236.1.207 Dr. Michael O'Mahony
Sarnia, Ontario
1236.1.211 Royal University Hospital
Saskatoon, Saskatchewan
1236.1.215 Cowan Avenue Medical Clinic
St. John's, Newfoundland and Labrador

Other trials in Canada

Mexico10 sites

1236.1.301 Fracc. Magallanes
Acapulco Guerrero
1236.1.304 Fracc Agricultura
Aguascalientes
1236.1.311 Hospital de Especialidades Miguel Hidalgo
Aguascalientes
1236.1.305 Especialidades Médicas del sol
Col Ciudad de Sol Zapopan
1236.1.310 Departamento de Hemodinamia
Col. Magdalena de Las Salinas
1236.1.307 Consultorio: Aurelio L
Guadalajara
1236.1.306
México D.F
1236.1.308 Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City
1236.1.302
Torreón
1236.1.303
Veracruz

Other trials in Mexico

Peru5 sites

1236.1.401 Unidad de Investigacion
Bella Vista, Callao,
1236.1.405
San Borja
1236.1.402
San Isidro
1236.1.403
San Isidro
1236.1.404
San Isidro

Other trials in Peru

Chile2 sites

1236.1.106 Hospital Dr. Sótero del Río
Puente Alto, Santiago de Chile
1236.1.103 Oficina 312 E (Cardiology Division)
Santiago

Other trials in Chile

About this study

Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study

Conditions: Hypertension
Being tested: Telmisartan, Ramipril
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelmisartanDrug
RamiprilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

Secondary outcomes (1)

Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Apr 2007

First posted25 Jan 2006 (estimated)
Study startApr 2006
Primary completionApr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Enrolment: 1,354 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00281593
Sponsor's protocol ID: 1236.1
Status last verified: Dec 2017
First submitted: 24 Jan 2006
Last updated: 28 Dec 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study
ClinicalTrials.gov ID: NCT00281593
Acronym / sponsor ID: 1236.1
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,354 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Apr 2007 (actual)
First posted: 25 Jan 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male and female patients >=18 years of age with Stage I or II hypertension defined as:
a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Key exclusion criteria (12 listed)

Pregnant
breast-feeding
unwilling to use birth control during the study
secondary hypertension
SBP>=180 mmHg

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telmisartan	Drug	–
Ramipril	Drug	–

Primary outcome

Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

1 secondary outcome

Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

119 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telmisartan and Ramipril in people with Hypertension, run by Boehringer Ingelheim at 119 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Argentina, Canada, Mexico, Peru and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281593.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.