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NCT00239538 · ClinicalTrials.gov registry record · Phase 4
SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 840
- Enrollment target
NCT00239538: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT00239538 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 840 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00239538, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 840 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG telmisartan combined with hydrochlorothiazide (80/12.5 mg)
- DRUG valsartan combined with hydrochlorothiazide (160/12.5mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 2003-01 |
| Est. Completion | 2004-12 |
| Phase | Phase 4 |
What the finished NCT00239538 record still lists
NCT00239538 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 2 interventions - of which telmisartan combined with hydrochlorothiazide (80/12.5 mg) is the first listed.
NCT00239538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00239538 about?
NCT00239538 is a clinical study titled "SMOOTH - Blood Pressure Control in Diabetic/Obese Patients". 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 pres...
What is the current status of trial NCT00239538?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 840 participants. The study started on 2003-01. Estimated completion is 2004-12.
What interventions are being tested in trial NCT00239538?
The interventions under investigation include: telmisartan combined with hydrochlorothiazide (80/12.5 mg) (DRUG), valsartan combined with hydrochlorothiazide (160/12.5mg) (DRUG).
Who is sponsoring clinical trial NCT00239538?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00239538's enrollment target sits among peer trials
840 90th of 2000 higher than 1,911 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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