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NCT01370005 · ClinicalTrials.gov registry record · Phase 3
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
A Phase 3 study of Hypertension and Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 825
- Enrollment target
- 20
- Study locations
NCT01370005: Completed Phase 3 study of Hypertension and Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
NCT01370005 is a Phase 3 study of Hypertension and Diabetes Mellitus, Type 2 that has completed, run by Boehringer Ingelheim. The registered enrollment target is 825 participants, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01370005, a Phase 3 study of Hypertension and Diabetes Mellitus, Type 2, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 825 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773
Primary Outcome
Change from baseline in HbA1c after 12 weeks of treatment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BI 10773
Study Locations (20)
Florida
- 1245.48.10008 Boehringer Ingelheim Investigational Site - Davie
- 1245.48.10025 Boehringer Ingelheim Investigational Site - Edgewater
- 1245.48.10001 Boehringer Ingelheim Investigational Site - Jacksonville
- 1245.48.10016 Boehringer Ingelheim Investigational Site - Miami
- 1245.48.10035 Boehringer Ingelheim Investigational Site - Palm Harbor
- 1245.48.10018 Boehringer Ingelheim Investigational Site - Pensacola
- 1245.48.10032 Boehringer Ingelheim Investigational Site - Pinellas Park
California
- 1245.48.10014 Boehringer Ingelheim Investigational Site - Lincoln
- 1245.48.10030 Boehringer Ingelheim Investigational Site - Long Beach
- 1245.48.10033 Boehringer Ingelheim Investigational Site - Long Beach
- 1245.48.10027 Boehringer Ingelheim Investigational Site - Los Angeles
- 1245.48.10041 Boehringer Ingelheim Investigational Site - Tustin
- 1245.48.10039 Boehringer Ingelheim Investigational Site - West Hills
Illinois
- 1245.48.10011 Boehringer Ingelheim Investigational Site - Addison
- 1245.48.10019 Boehringer Ingelheim Investigational Site - Arlington Heights
- 1245.48.10022 Boehringer Ingelheim Investigational Site - Chicago
Alabama
- 1245.48.10024 Boehringer Ingelheim Investigational Site - Huntsville
Arizona
- 1245.48.10002 Boehringer Ingelheim Investigational Site - Phoenix
Georgia
- 1245.48.10012 Boehringer Ingelheim Investigational Site - Marietta
Kansas
- 1245.48.10017 Boehringer Ingelheim Investigational Site - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 825 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01370005 record still lists
NCT01370005 is an interventional study that assigns participants to a tested intervention. The registered 825 participants enrollment target is mid-sized for trials with a published cap, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01370005 names 20 study sites across 7 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01370005 about?
NCT01370005 is a clinical study titled "12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus". This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensi...
What is the current status of trial NCT01370005?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 825 participants. The study started on 2011-06. Estimated completion is 2012-07.
What conditions does trial NCT01370005 study?
This clinical trial studies the following conditions: Hypertension, Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01370005?
The interventions under investigation include: Placebo (DRUG), BI 10773 (DRUG).
Who is sponsoring clinical trial NCT01370005?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01370005 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01370005's enrollment target sits among peer trials
825 86th of 470 higher than 385 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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.
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