Trial Outcomes & Findings for The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months (NCT NCT00224133)

NCT ID: NCT00224133

Last Updated: 2010-04-27

Results Overview

All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 661 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2010-04-27

Participant Flow

Participant milestones

Measure	8 mg Silodosin Per Day With Food
Overall Study STARTED	661
Overall Study COMPLETED	435
Overall Study NOT COMPLETED	226

Reasons for withdrawal

Measure	8 mg Silodosin Per Day With Food
Overall Study Adverse Event	93
Overall Study Protocol Violation	6
Overall Study Withdrawal by Subject	33
Overall Study Lack of Efficacy	58
Overall Study Lost to Follow-up	21
Overall Study Physician Decision	1
Overall Study Other	14

Baseline Characteristics

The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

Baseline characteristics by cohort

Measure	8 mg Silodosin Per Day With Food n=661 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	356 Participants n=5 Participants
Age, Categorical >=65 years	305 Participants n=5 Participants
Age Continuous	65.0 years STANDARD_DEVIATION 7.79 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	661 Participants n=5 Participants
Region of Enrollment United States	661 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Safety population was analyzed. This population is defined as all enrolled patients who received at least one dose of study drug.

All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.

Outcome measures

Measure	8 mg Silodosin Per Day With Food n=661 Participants
Adverse Events Patients with at least 1 adverse event	431 participants
Adverse Events Patients with drug related adverse event	188 participants
Adverse Events Patients with a serious adverse events	29 participants
Adverse Events Patients with a drug related serious adverse event	0 participants
Adverse Events Patients discontinued due to an adverse event	86 participants
Adverse Events Discontinued for drug related adverse event	54 participants

SECONDARY outcome

Timeframe: 9 months

The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.

Outcome measures

Outcome data not reported

Adverse Events

8 mg Silodosin Per Day With Food

Serious events: 29 serious events

Other events: 138 other events

Deaths: 0 deaths

Serious adverse events

Measure	8 mg Silodosin Per Day With Food n=661 participants at risk
Cardiac disorders Acute myocardial infarction	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Vascular disorders Aneurysm	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Cardiac disorders Arrythmia	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Cardiac disorders Atrial fibrillation	0.30% 2/661 • Number of events 2 • 9 months No subject experienced a serious adverse event that was related to treatment.
Injury, poisoning and procedural complications Back injury	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Nervous system disorders Carotid artery stenosis	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Injury, poisoning and procedural complications Concussion	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Vascular disorders Deep vein thrombosis	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Infections and infestations Diverticulitis	0.30% 2/661 • Number of events 2 • 9 months No subject experienced a serious adverse event that was related to treatment.
Vascular disorders Femoral artery occlusion	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Gastrointestinal disorders Gastritis	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Surgical and medical procedures Hip arthroplasty	0.30% 2/661 • Number of events 2 • 9 months No subject experienced a serious adverse event that was related to treatment.
Surgical and medical procedures Knee arthroplasty	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Infections and infestations Lobar pneumonia	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.45% 3/661 • Number of events 3 • 9 months No subject experienced a serious adverse event that was related to treatment.
Cardiac disorders Myocardial infarction	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Nervous system disorders Nerve root lesion	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.61% 4/661 • Number of events 4 • 9 months No subject experienced a serious adverse event that was related to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.30% 2/661 • Number of events 2 • 9 months No subject experienced a serious adverse event that was related to treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.30% 2/661 • Number of events 2 • 9 months No subject experienced a serious adverse event that was related to treatment.
Surgical and medical procedures Spinal laminectomy	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.
Nervous system disorders Transient ischemic attack	0.15% 1/661 • Number of events 1 • 9 months No subject experienced a serious adverse event that was related to treatment.

Other adverse events

Measure	8 mg Silodosin Per Day With Food n=661 participants at risk
Reproductive system and breast disorders Retrograde ejaculation	20.9% 138/661 • Number of events 139 • 9 months No subject experienced a serious adverse event that was related to treatment.

Additional Information

Gary Hoel, RPh, PhD, Executive Director of Clinical Research

Watson Laboratories, Inc.

Phone: 801-588-6641

Email: gary.hoel@watson.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60