SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
Public ClinicalTrials.gov record NCT00239538. 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
Prospective, Randomized, Open-label, Blinded Endpoint, Forced Titration Study to Compare Telmisartan Combined With HCTZ (80mg/12.5mg), to Valsartan Combined With HCTZ (160mg/12.5mg), for the Control of Mild-to-moderate Hypertension in Obese Patients With Type 2 Diabetes Mellitus Using ABPM.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to demonstrate that telmisartan 80 mg combined with hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval at the end of a 10-week treatment period in mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus
Study identification
- NCT ID
- NCT00239538
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 840 participants
Conditions and interventions
Conditions
Interventions
- telmisartan combined with hydrochlorothiazide (80/12.5 mg) Drug
- valsartan combined with hydrochlorothiazide (160/12.5mg) Drug
Drug
Eligibility (public fields only)
- Age range
- 30 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
- Jan 2003 (Type not available)
- Primary completion
- Dec 2004 (Actual)
- Completion
- Dec 2004 (Type not available)
- Last update posted
- Nov 8, 2013
2003 – 2004
United States locations
- U.S. sites
- 60
- U.S. states
- 24
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cooper Green Hospital | Birmingham | Alabama | 35223 | — |
| Boehringer Ingelheim Investigational Site | Birmingham | Alabama | 35294-2041 | — |
| Boehringer Ingelheim Investigational Site | Huntsville | Alabama | 35801 | — |
| Boehringer Ingelheim Investigational Site | Mobile | Alabama | 36608 | — |
| Boehringer Ingelheim Investigational Site | Glendale | Arizona | 85306 | — |
| Boehringer Ingelheim Investigational Site | Tucson | Arizona | 85712 | — |
| Memorial Research Medical Clinic | Long Beach | California | 90806 | — |
| 1200 | Los Angeles | California | 90033 | — |
| Boehringer Ingelheim Investigational Site | Los Angeles | California | 90057 | — |
| 8615 | Nuena Park | California | 90620 | — |
| Boehringer Ingelheim Investigational Site | Orange | California | 92868 | — |
| Boehringer Ingelheim Investigational Site | Sacramento | California | 95825 | — |
| Boehringer Ingelheim Investigational Site | Sacramento | California | 95841 | — |
| 595 | San Francisco | California | 94132 | — |
| 1805 | Stockton | California | 95204 | — |
| Boehringer Ingelheim Investigational Site | Torrance | California | 90505 | — |
| 2311 | Washington D.C. | District of Columbia | 20037 | — |
| Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | 33308-4311 | — |
| Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | 33308 | — |
| 6448 | Hollywood | Florida | 33023 | — |
| Boehringer Ingelheim Investigational Site | Melbourne | Florida | 32901 | — |
| Attention: Larry I. Gilderman, D.O. | Pembroke Pines | Florida | 33024 | — |
| Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | 33027 | — |
| Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | 33028 | — |
| Boehringer Ingelheim Investigational Site | Pinellas Park | Florida | 33781 | — |
| Boehringer Ingelheim Investigational Site | West Palm Beach | Florida | 33401 | — |
| Herron Medical Center, Ltd. | Chicago | Illinois | 60610 | — |
| Boehringer Ingelheim Investigational Site | Chicago | Illinois | 60612 | — |
| Boehringer Ingelheim Investigational Site | Orland Park | Illinois | 60462 | — |
| Boehringer Ingelheim Investigational Site | Evansville | Indiana | 47710 | — |
| Boehringer Ingelheim Investigational Site | Evansville | Indiana | 47713 | — |
| Boehringer Ingelheim Investigational Site | Shawnee | Kansas | 66216 | — |
| Boehringer Ingelheim Investigational Site | Wichita | Kansas | 67212 | — |
| Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | 70119 | — |
| Boehringer Ingelheim Investigational Site | Baltimore | Maryland | 21204 | — |
| 200 | Baltimore | Maryland | 21218 | — |
| Boehringer Ingelheim Investigational Site | Kansas City | Missouri | 64114 | — |
| 12401 | St Louis | Missouri | 63141 | — |
| Boehringer Ingelheim Investigational Site | Missoula | Montana | 59802 | — |
| Boehringer Ingelheim Investigational Site | Brooklyn | New York | 11203 | — |
| 3 | Buffalo | New York | 14209 | — |
| Comprehensive Clinical Research | Bina | North Carolina | 08009 | — |
| Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| Boehringer Ingelheim Investigational Site | Kettering | Ohio | 45429 | — |
| Boehringer Ingelheim Investigational Site | Marion | Ohio | 43302 | — |
| Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | 73132-4904 | — |
| Boehringer Ingelheim Investigational Site | Portland | Oregon | 97232 | — |
| Boehringer Ingelheim Investigational Site | Broomal | Pennsylvania | 19008 | — |
| 6605 | Bartlett | Tennessee | 38134 | — |
| 108 | Fayetteville | Tennessee | 37334 | — |
| Boehringer Ingelheim Investigational Site | Carrollton | Texas | 75006 | — |
| 7777 | Dallas | Texas | 75230 | — |
| Boehringer Ingelheim Investigational Site | El Paso | Texas | 79912 | — |
| Team Research of Texas | Harker Heights | Texas | 76548 | — |
| Boehringer Ingelheim Investigational Site | San Antonio | Texas | 78217 | — |
| Boehringer Ingelheim Investigational Site | San Antonio | Texas | 78229-4801 | — |
| 420 | Salt Lake City | Utah | 84111 | — |
| 20901 | Ettrick | Virginia | 23803 | — |
| Boehringer Ingelheim Investigational Site | Spokane | Washington | 99207 | — |
| 5000 | Miwaukee | Wisconsin | 53295 | — |
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 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00239538, 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 Nov 8, 2013 · Synced Oct 19, 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 NCT00239538 live on ClinicalTrials.gov.