Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
Public ClinicalTrials.gov record NCT00860262. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.
Study identification
- NCT ID
- NCT00860262
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 858 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2009 (Type not available)
- Primary completion
- Dec 2009 (Actual)
- Completion
- Not listed
- Last update posted
- May 20, 2014
Started 2009
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1235.20.525 Boehringer Ingelheim Investigational Site | Buena Park | California | — | — |
| 1235.20.503 Boehringer Ingelheim Investigational Site | Long Beach | California | — | — |
| 1235.20.507 Boehringer Ingelheim Investigational Site | Long Beach | California | — | — |
| 1235.20.529 Boehringer Ingelheim Investigational Site | Roseville | California | — | — |
| 1235.20.518 Boehringer Ingelheim Investigational Site | Tustin | California | — | — |
| 1235.20.521 Boehringer Ingelheim Investigational Site | Westlake Village | California | — | — |
| 1235.20.508 Boehringer Ingelheim Investigational Site | DeLand | Florida | — | — |
| 1235.20.506 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1235.20.519 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | — | — |
| 1235.20.523 Boehringer Ingelheim Investigational Site | Port Orange | Florida | — | — |
| 1235.20.528 Boehringer Ingelheim Investigational Site | Blue Ridge | Georgia | — | — |
| 1235.20.516 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | — | — |
| 1235.20.527 Boehringer Ingelheim Investigational Site | Bay City | Michigan | — | — |
| 1235.20.510 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | — | — |
| 1235.20.512 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | — | — |
| 1235.20.509 Boehringer Ingelheim Investigational Site | The Bronx | New York | — | — |
| 1235.20.511 Boehringer Ingelheim Investigational Site | Kettering | Ohio | — | — |
| 1235.20.515 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | — | — |
| 1235.20.534 Boehringer Ingelheim Investigational Site | Medford | Oregon | — | — |
| 1235.20.526 Boehringer Ingelheim Investigational Site | Erie | Pennsylvania | — | — |
| 1235.20.513 Boehringer Ingelheim Investigational Site | Tipton | Pennsylvania | — | — |
| 1235.20.517 Boehringer Ingelheim Investigational Site | Providence | Rhode Island | — | — |
| 1235.20.522 Boehringer Ingelheim Investigational Site | Carrollton | Texas | — | — |
| 1235.20.520 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1235.20.530 Boehringer Ingelheim Investigational Site | Killeen | Texas | — | — |
| 1235.20.535 Boehringer Ingelheim Investigational Site | Draper | Utah | — | — |
| 1235.20.533 Boehringer Ingelheim Investigational Site | Magna | Utah | — | — |
| 1235.20.505 Boehringer Ingelheim Investigational Site | Saratoga Springs | Utah | — | — |
| 1235.20.537 Boehringer Ingelheim Investigational Site | Tacoma | Washington | — | — |
| 1235.20.501 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 107 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00860262, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2014 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00860262 live on ClinicalTrials.gov.