An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01726270
First received: November 9, 2012
Last updated: June 13, 2013
Last verified: June 2013
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Purpose
Multicenter trial conducted in Pharmacy retail centers
| Condition | Intervention | Phase |
|---|---|---|
|
Lower Urinary Tract Symptoms |
Drug: tamsulosin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
| Enrollment: | 363 |
| Study Start Date: | November 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: tamsulosin hydrochloride
patients will take drug for 8 weeks in this exploratory study
|
Drug: tamsulosin
0.4 mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Men 18 years of age and older.
- Able to speak, read and understand English.
- Willing to participate in the study and voluntarily sign an informed consent document.
Exclusion criteria:
1. Subject or anyone in their household is currently employed by a marketing or marketing research company, and advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company as a healthcare professional or healthcare practice.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726270
Locations
| United States, Alabama | |
| 527.82.170 Boehringer Ingelheim Investigational Site | |
| Hoover, Alabama, United States | |
| United States, Arizona | |
| 527.82.167 Boehringer Ingelheim Investigational Site | |
| Mesa, Arizona, United States | |
| United States, California | |
| 527.82.177 Boehringer Ingelheim Investigational Site | |
| Encino, California, United States | |
| 527.82.168 Boehringer Ingelheim Investigational Site | |
| Garden Grove, California, United States | |
| 527.82.171 Boehringer Ingelheim Investigational Site | |
| La Habra, California, United States | |
| United States, Minnesota | |
| 527.82.161 Boehringer Ingelheim Investigational Site | |
| Anoka, Minnesota, United States | |
| 527.82.179 Boehringer Ingelheim Investigational Site | |
| Elk River, Minnesota, United States | |
| 527.82.163 Boehringer Ingelheim Investigational Site | |
| Fridley, Minnesota, United States | |
| 527.82.165 Boehringer Ingelheim Investigational Site | |
| Roseville, Minnesota, United States | |
| 527.82.166 Boehringer Ingelheim Investigational Site | |
| St. Francis, Minnesota, United States | |
| United States, New Mexico | |
| 527.82.176 Boehringer Ingelheim Investigational Site | |
| Albuquerque, New Mexico, United States | |
| United States, Texas | |
| 527.82.181 Boehringer Ingelheim Investigational Site | |
| Longview, Texas, United States | |
| 527.82.160 Boehringer Ingelheim Investigational Site | |
| Tyler, Texas, United States | |
| United States, Utah | |
| 527.82.162 Boehringer Ingelheim Investigational Site | |
| Bountiful, Utah, United States | |
| 527.82.180 Boehringer Ingelheim Investigational Site | |
| Layton, Utah, United States | |
| 527.82.173 Boehringer Ingelheim Investigational Site | |
| Salt Lake City, Utah, United States | |
| 527.82.174 Boehringer Ingelheim Investigational Site | |
| Syracuse, Utah, United States | |
| United States, Virginia | |
| 527.82.169 Boehringer Ingelheim Investigational Site | |
| Richmond, Virginia, United States | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01726270 History of Changes |
| Other Study ID Numbers: | 527.82 |
| Study First Received: | November 9, 2012 |
| Last Updated: | June 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Tamsulosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013