Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00281593
Collaborator
(none)
1,354
119
11.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1354 participants
Primary Purpose:
Treatment
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
Study Start Date
:
Apr 1, 2006
Actual Primary Completion Date
:
Apr 1, 2007
Outcome Measures
Primary Outcome Measures
- Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Pregnant
-
breast-feeding
-
unwilling to use birth control during the study
-
secondary hypertension
-
SBP>=180 mmHg
-
DBP>=120 mmHg
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1236.1.511 Boehringer Ingelheim Investigational Site | Glendale | Arizona | United States | |
| 2 | 1236.1.574 Boehringer Ingelheim Investigational Site | Tempe | Arizona | United States | |
| 3 | 1236.1.501 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |
| 4 | 1236.1.557 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |
| 5 | 1236.1.523 Boehringer Ingelheim Investigational Site | Buena Park | California | United States | |
| 6 | 1236.1.514 Boehringer Ingelheim Investigational Site | Concord | California | United States | |
| 7 | 1236.1.560 Boehringer Ingelheim Investigational Site | Encinitas | California | United States | |
| 8 | 1236.1.573 Boehringer Ingelheim Investigational Site | Long Beach | California | United States | |
| 9 | 1236.1.516 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 10 | 1236.1.529 Boehringer Ingelheim Investigational Site | Roseville | California | United States | |
| 11 | 1236.1.519 Boehringer Ingelheim Investigational Site | Tustin | California | United States | |
| 12 | 1236.1.543 Boehringer Ingelheim Investigational Site | Westlake Village | California | United States | |
| 13 | 1236.1.528 Boehringer Ingelheim Investigational Site | Boulder | Colorado | United States | |
| 14 | 1236.1.530 Boehringer Ingelheim Investigational Site | Farmington | Connecticut | United States | |
| 15 | 1236.1.572 Boehringer Ingelheim Investigational Site | DeLand | Florida | United States | |
| 16 | 1236.1.577 Boehringer Ingelheim Investigational Site | Hialeah | Florida | United States | |
| 17 | 1236.1.526 Boehringer Ingelheim Investigational Site | Jupiter | Florida | United States | |
| 18 | 1236.1.527 Boehringer Ingelheim Investigational Site | Largo | Florida | United States | |
| 19 | 1236.1.503 Anchor Research Center | Naples | Florida | United States | |
| 20 | 1236.1.520 Boehringer Ingelheim Investigational Site | New Port Richey | Florida | United States | |
| 21 | 1236.1.571 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 22 | 1236.1.565 Boehringer Ingelheim Investigational Site | Blue Ridge | Georgia | United States | |
| 23 | 1236.1.538 Boehringer Ingelheim Investigational Site | Meridian | Idaho | United States | |
| 24 | 1236.1.532 Boehringer Ingelheim Investigational Site | Peoria | Illinois | United States | |
| 25 | 1236.1.553 Boehringer Ingelheim Investigational Site | Avon | Indiana | United States | |
| 26 | 1236.1.546 River Cities Cardiology Research Inst of Middle America | Jeffersonville | Indiana | United States | |
| 27 | 1236.1.563 Boehringer Ingelheim Investigational Site | Valparaiso | Indiana | United States | |
| 28 | 1236.1.517 Boehringer Ingelheim Investigational Site | Newton | Kansas | United States | |
| 29 | 1236.1.531 Boehringer Ingelheim Investigational Site | Wichita | Kansas | United States | |
| 30 | 1236.1.566 Boehringer Ingelheim Investigational Site | Richmond | Kentucky | United States | |
| 31 | 1236.1.551 Boehringer Ingelheim Investigational Site | Auburn | Maine | United States | |
| 32 | 1236.1.536 Boehringer Ingelheim Investigational Site | Haverhill | Massachusetts | United States | |
| 33 | 1236.1.576 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | United States | |
| 34 | 1236.1.561 Clinical Research Center of Cape Cod | West Yarmouth | Massachusetts | United States | |
| 35 | 1236.1.555 Boehringer Ingelheim Investigational Site | Cadillac | Michigan | United States | |
| 36 | 1236.1.509 Boehringer Ingelheim Investigational Site | Troy | Michigan | United States | |
| 37 | 1236.1.541 Boehringer Ingelheim Investigational Site | Excelsior Springs | Missouri | United States | |
| 38 | 1236.1.556 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States | |
| 39 | 1236.1.525 Physicians Research Center, LLC, Toms River | Toms River | New Jersey | United States | |
| 40 | 1236.1.508 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 41 | 1236.1.522 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 42 | 1236.1.542 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States | |
| 43 | 1236.1.547 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 44 | 1236.1.567 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 45 | 1236.1.515 Boehringer Ingelheim Investigational Site | Kettering | Ohio | United States | |
| 46 | 1236.1.575 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States | |
| 47 | 1236.1.554 Boehringer Ingelheim Investigational Site | Corvallis | Oregon | United States | |
| 48 | 1236.1.524 Boehringer Ingelheim Investigational Site | Eugene | Oregon | United States | |
| 49 | 1236.1.544 Boehringer Ingelheim Investigational Site | Medford | Oregon | United States | |
| 50 | 1236.1.545 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States | |
| 51 | 1236.1.569 Boehringer Ingelheim Investigational Site | Erie | Pennsylvania | United States | |
| 52 | 1236.1.505 Ledeeach Family Medicine | Harleysville | Pennsylvania | United States | |
| 53 | 1236.1.564 Boehringer Ingelheim Investigational Site | Tipton | Pennsylvania | United States | |
| 54 | 1236.1.534 Boehringer Ingelheim Investigational Site | Cumberland | Rhode Island | United States | |
| 55 | 1236.1.539 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States | |
| 56 | 1236.1.568 Boehringer Ingelheim Investigational Site | Carrollton | Texas | United States | |
| 57 | 1236.1.549 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 58 | 1236.1.559 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 59 | 1236.1.548 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 60 | 1236.1.550 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 61 | 1236.1.570 Boehringer Ingelheim Investigational Site | The Colony | Texas | United States | |
| 62 | 1236.1.510 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States | |
| 63 | 1236.1.513 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States | |
| 64 | 1236.1.521 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States | |
| 65 | 1236.1.512 Boehringer Ingelheim Investigational Site | Sandy | Utah | United States | |
| 66 | 1236.1.535 Boehringer Ingelheim Investigational Site | Sandy | Utah | United States | |
| 67 | 1236.1.502 Boehringer Ingelheim Investigational Site | Falls Church | Virginia | United States | |
| 68 | 1236.1.504 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States | |
| 69 | 1236.1.540 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States | |
| 70 | 1236.1.562 Boehringer Ingelheim Investigational Site | Menomonee Falls | Wisconsin | United States | |
| 71 | 1236.1.601 Boehringer Ingelheim Investigational Site | Buenos aIRES | Argentina | ||
| 72 | 1236.1.604 Boehringer Ingelheim Investigational Site | Buenos Aires | Argentina | ||
| 73 | 1236.1.605 Boehringer Ingelheim Investigational Site | Buenos Aires | Argentina | ||
| 74 | 1236.1.610 | Buenos Aires | Argentina | ||
| 75 | 1236.1.612 | Buenos Aires | Argentina | ||
| 76 | 1236.1.619 | Capital Federal,Buenos Aires | Argentina | ||
| 77 | 1236.1.608 | Capital Federal | Argentina | ||
| 78 | 1236.1.618 Hospital Ramos Mejia | Capital Federal | Argentina | ||
| 79 | 1236.1.615 | CordobaCordoba | Argentina | ||
| 80 | 1236.1.603 Boehringer Ingelheim Investigational Site | Cordoba | Argentina | ||
| 81 | 1236.1.611 | Corrientes | Argentina | ||
| 82 | 1236.1.606 | Córdoba | Argentina | ||
| 83 | 1236.1.613 | Córdoba | Argentina | ||
| 84 | 1236.1.614 | Córdoba | Argentina | ||
| 85 | 1236.1.609 | Derqui | Argentina | ||
| 86 | 1236.1.624 Instituto de Investigaciones Clínicas | Mar Del Plata | Argentina | ||
| 87 | 1236.1.620 DIM - Clinica Privada | Ramos Mejía | Argentina | ||
| 88 | 1236.1.622 Hospital San Bernardo | Salta | Argentina | ||
| 89 | 1236.1.621 Clinica del Torax y Especialidades | Santa Fe | Argentina | ||
| 90 | 1236.1.602 Boehringer Ingelheim Investigational Site | vILLA carlos paz | Argentina | ||
| 91 | 1236.1.616 | Zárate | Argentina | ||
| 92 | 1236.1.202 North Road Medical Centre | Coquitlam | British Columbia | Canada | |
| 93 | 1236.1.208 Shoppers Drug Mart Building | Bay Roberts | Newfoundland and Labrador | Canada | |
| 94 | 1236.1.206 77 Commonwealth Avenue | Mount Pearl | Newfoundland and Labrador | Canada | |
| 95 | 1236.1.215 Cowan Avenue Medical Clinic | St. John's | Newfoundland and Labrador | Canada | |
| 96 | 1236.1.203 MSHJ Research Associates | Halifax | Nova Scotia | Canada | |
| 97 | 1236.1.210 Hamilton Medical Research | Hamilton | Ontario | Canada | |
| 98 | 1236.1.204 Dr. Ivan Jagas | Kitchener | Ontario | Canada | |
| 99 | 1236.1.209 St. Joseph Cardiovascular Inc | Ottawa | Ontario | Canada | |
| 100 | 1236.1.207 Dr. Michael O'Mahony | Sarnia | Ontario | Canada | |
| 101 | 1236.1.205 Ctr. Hospital U Quebec- Pav CHUL | Sainte-Foy | Quebec | Canada | |
| 102 | 1236.1.211 Royal University Hospital | Saskatoon | Saskatchewan | Canada | |
| 103 | 1236.1.106 Hospital Dr. Sótero del Río | Puente Alto, Santiago De Chile | Chile | ||
| 104 | 1236.1.103 Oficina 312 E (Cardiology Division) | Santiago de Chile | Chile | ||
| 105 | 1236.1.301 Fracc. Magallanes | Acapulco Guerrero | Mexico | ||
| 106 | 1236.1.304 Fracc Agricultura | Aguascalientes | Mexico | ||
| 107 | 1236.1.311 Hospital de Especialidades Miguel Hidalgo | Aguascalientes | Mexico | ||
| 108 | 1236.1.305 Especialidades Médicas del sol | Col Ciudad De Sol Zapopan | Mexico | ||
| 109 | 1236.1.310 Departamento de Hemodinamia | Col. Magdalena De Las Salinas | Mexico | ||
| 110 | 1236.1.307 Consultorio: Aurelio L | Guadalajara | Mexico | ||
| 111 | 1236.1.306 | México D.F | Mexico | ||
| 112 | 1236.1.308 Hospital Central "Dr. Ignacio Morones Prieto" | San Luis Potosí | Mexico | ||
| 113 | 1236.1.302 | Torreón, | Mexico | ||
| 114 | 1236.1.303 | Veracruz | Mexico | ||
| 115 | 1236.1.401 Unidad de Investigacion | Bella Vista, Callao, | Peru | ||
| 116 | 1236.1.405 | San Borja. | Peru | ||
| 117 | 1236.1.403 | San Isidro. | Peru | ||
| 118 | 1236.1.402 | San Isidro | Peru | ||
| 119 | 1236.1.404 | San Isidro | Peru |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00281593
Other Study ID Numbers:
- 1236.1
First Posted:
Jan 25, 2006
Last Update Posted:
Dec 28, 2017
Last Verified:
Dec 1, 2017