Prostatic HyperplasiaPhase 4NCT02244255
FLOMAX® Versus HYTRIN® in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia
A Phase 4 study testing FLOMAX® capsules and Ascending doses of HYTRIN® capsules in people with Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
1. To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the signs and symptoms of benign prostatic hyperplasia (BPH) 2. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- FLOMAX® capsules and Ascending doses of HYTRIN® capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,993 participants
- Where
- No sites listed yet
- Study dates
- Aug 1998to Jun 2000
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients (45 years of age or older) diagnosed with benign prostatic hyperplasia
- Patients with a total score on the AUA Symptom Index for BPH of at least 13 points at each of the three initial visits (Visits 1, 2 and 3)
- A baseline prostate specific antigen (PSA) of ≤ 4.0 ng/ml
- Patients who are able to give written informed consent before performing screening examinations or tests
- Patients being judged by the investigator to be reliable and able to follow protocol procedures (including the return visits schedule), and cooperate in the completion of tests related to safety and efficacy
Who cannot join
- Patients with a history of an allergy to alpha blockers, alpha/beta blockers or patients who have had a "first dose hypotensive episode" upon starting therapy with an alpha blocker
- Patients who are currently being treated or who, in the last 3 months, have been treated with finasteride
- Participated in an investigational drug study within 4 weeks prior to starting placebo phase
- Patients taking medication in the following classes and unable to discontinue them at least two weeks before the study and for the duration of the study
- Alpha adrenergic blocking agents
- Alpha adrenergic agonists
Show all 47Show fewer
- Drugs with anticholinergic activity (including antihistamines)
- Antispasmodics
- Parasympathomimetics and cholinomimetics
- Peripheral or central neurologic disease including, but not limited to, transient ischemic attacks, stroke, dementia, multiple sclerosis, spinal cord injury, recurrent episodes of dizziness, vertigo, or loss of consciousness, clinically evident diabetic neuropathy, brain and/or spinal cord tumors
- History of a pathological fall (unintentional change in body position) occurring under circumstances in which normal homeostatic mechanisms would ordinarily maintain stability, or syncope during the last year
- More than one episode of angina within the past 6 months
- Ambulation requiring assistance (i.e., canes, walkers, etc.)
- Documented myocardial infarction (by ECG) within the past 6 months or evidence of a myocardial infarction on ECG whose age cannot be determined
- New York Heart Association Class III or IV congestive heart failure
- Prosthetic heart valves, cardiac devices or prior history of endocarditis
- Clinically significant cardiac arrhythmias either diagnosed by ECG or recorded in the medical history, whether or not accompanied by symptoms (e.g., dizziness, presyncope, syncope, unsteadiness)
- Infravesical obstruction by history due to:
- Vesical neck contracture
- Clinical suspicion of prostate carcinoma
- Mullerian duct cysts
- Urethral obstruction due to stricture, valves, sclerosis or urethral tumor
- Inflammatory or infectious conditions
- Detrusor-sphincter dyssynergia
- Prior transurethral resection of the prostate (TURP) or open prostatectomy
- History of instrumentation of the urinary tract (cytoscopy or catheterization) within 30 days prior to the start of the study
- Prior pelvic surgery for malignancy or bowel resection
- History or diagnosis of genitourinary malignancy
- History of an episode of acute urinary retention within three months prior to the start of the study. (Urinary retention is to be considered acute if the patient has to be sent to a hospital for catheterization)
- Patients with the current diagnosis of either bladder, ureter, or kidney stones
- Patients with a current diagnosis of suspected prostatitis
- Patients with a history of a neurogenic bladder
- Urinary tract infection (i.e., positive urine culture) yielding pathogenic bacteria > 10**5 colony forming units (CFU) per milliliter in a properly obtained clean voided urine specimen which has been properly cultured or a laboratory report of a urinary tract infection or signs/symptoms indicative of a urinary tract infection such as [increased WBC's in the urine (15-30 white blood cells (WBC)/high powered field), dysuria, costovertebral tenderness, and urinary frequency accompanied by fever] within four weeks of baseline (Visit 3)
- Evidence of significant renal dysfunction based upon a serum creatinine greater than two times the upper limit of normal levels established by the central laboratory used in this study
- Laboratory tests during the screening phase:
- Hemoglobin: < 12.0 g/dL
- Leukocytes: < 3000/mm3
- Liver Enzymes: (serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), and alkaline phosphatase): more than two times the upper limit of normal levels established by the central laboratory used in the study
- Clinically relevant conditions which might interfere with the patient's ability to participate in the study including, but not limited to, the following: neurologic, gastrointestinal, cardiovascular including uncontrolled hypertension defined as a sitting diastolic blood pressure ≥ 95 mmHg with or without treatment, hepatic, renal, psychiatric, hematologic or respiratory disease, clinically relevant laboratory abnormalities based upon the investigator's judgment
- Hypertensive patients initially using HYTRIN® as a monotherapy for both hypertension and BPH
- Patients with cancer or diagnosis of cancer within five years of baseline
- Patients who have been receiving cimetidine, warfarin, or herbal medications specifically for treatment of any urological problems within four weeks prior to the baseline
- Patients who show poor compliance in the initial placebo period by:
- not returning unused medication bottles for Visits 2 or 3
- having taken < 80% or > 120% of prescribed doses during any visit interval between Visit (1, 2 or 3)
- Postural symptoms during the initial placebo period, e.g., lightheadedness (on more than three occasions), fainting, blurring or loss of vision, profound weakness, or unsteadiness, with or without a change in blood pressure and/or pulse rate
- Patients with poorly controlled diabetes mellitus (urine positive for glucose (> 1+) on each of 2 urinalyses during the placebo evaluation period)
About this study
Official title: An Eleven-Week, Open-Label, Randomized, Multicenter, Parallel-Design, Placebo Lead-in Study of FLOMAX® Capsules, 0.4 mg Daily Versus HYTRIN® Capsules, 5 mg (With Titration) Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia
- To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the signs and symptoms of benign prostatic hyperplasia (BPH)
- To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the symptoms of benign prostatic hyperplasia
- Conditions
- Prostatic Hyperplasia
- Being tested
- FLOMAX® capsules, Ascending doses of HYTRIN® capsules
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOMAX® capsulesDrug
Also called Tamsulosin hydrochloride
Ascending doses of HYTRIN® capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| FLOMAX® | Experimental | Not described Receives: Drug: FLOMAX® capsules |
| HYTRIN® | Active comparator | Not described Receives: Drug: Ascending doses of HYTRIN® capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in American Urological Association (AUA) symptom score index
Measured: Pre-dose, up to day 57 after start of treatment
Secondary outcomes (7)
Changes in AUA bother score index
Validated quality of life questionnaire for urinary problems containing:
- AUA obstructive symptom score
- AUA irritative symptom score
- AUA nocturia symptom score
Measured: Pre-dose, up to 57days after start of treatment
Changes in BPH impact index score
Measured: Pre-dose, up to 57 days after start of treatment
Global assessment by investigator on a 5-point scale
Measured: Day 5, up to day 57 after start of treatment
Number of patients with clinically relevant changes from baselinein laboratory values
Measured: Pre-dose, day 57 after start of treatment
Number of patients with clinically significant changes in vital signs
Measured: Pre-dose, up to 57 days after start of treatment
Number of patients with clinically relevant changes from baseline in ECG
Measured: Pre-dose, up to 57 days after start of treatment
Number of patients with adverse events
Measured: Up to day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startAug 1998
- Primary completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,993 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244255
- Sponsor's protocol ID
- 527.17
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eleven-Week, Open-Label, Randomized, Multicenter, Parallel-Design, Placebo Lead-in Study of FLOMAX® Capsules, 0.4 mg Daily Versus HYTRIN® Capsules, 5 mg (With Titration) Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02244255
- Acronym / sponsor ID
- 527.17
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,993 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- Primary completion
- Jun 2000 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the signs and symptoms of benign prostatic hyperplasia (BPH)
- To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the symptoms of benign prostatic hyperplasia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLOMAX® | Experimental | Drug: FLOMAX® capsules |
| HYTRIN® | Active comparator | Drug: Ascending doses of HYTRIN® capsules |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients (45 years of age or older) diagnosed with benign prostatic hyperplasia
- Patients with a total score on the AUA Symptom Index for BPH of at least 13 points at each of the three initial visits (Visits 1, 2 and 3)
- A baseline prostate specific antigen (PSA) of ≤ 4.0 ng/ml
- Patients who are able to give written informed consent before performing screening examinations or tests
- Patients being judged by the investigator to be reliable and able to follow protocol procedures (including the return visits schedule), and cooperate in the completion of tests related to safety and efficacy
Key exclusion criteria (47 listed)
- Patients with a history of an allergy to alpha blockers, alpha/beta blockers or patients who have had a "first dose hypotensive episode" upon starting therapy with an alpha blocker
- Patients who are currently being treated or who, in the last 3 months, have been treated with finasteride
- Participated in an investigational drug study within 4 weeks prior to starting placebo phase
- Patients taking medication in the following classes and unable to discontinue them at least two weeks before the study and for the duration of the study
- Peripheral or central neurologic disease including, but not limited to, transient ischemic attacks, stroke, dementia, multiple sclerosis, spinal cord injury, recurrent episodes of dizziness, vertigo, or loss of consciousness, clinically evident diabetic neuropathy, brain and/or spinal cord tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLOMAX® capsulesAlso: Tamsulosin hydrochloride | Drug | FLOMAX® |
| Ascending doses of HYTRIN® capsules | Drug | HYTRIN® |
Primary outcome
Changes in American Urological Association (AUA) symptom score index
Time frame: Pre-dose, up to day 57 after start of treatment
7 secondary outcomes
Changes in AUA bother score index
Time frame: Pre-dose, up to 57days after start of treatment
Changes in BPH impact index score
Time frame: Pre-dose, up to 57 days after start of treatment
Global assessment by investigator on a 5-point scale
Time frame: Day 5, up to day 57 after start of treatment
Number of patients with clinically relevant changes from baselinein laboratory values
Time frame: Pre-dose, day 57 after start of treatment
Number of patients with clinically significant changes in vital signs
Time frame: Pre-dose, up to 57 days after start of treatment
Number of patients with clinically relevant changes from baseline in ECG
Time frame: Pre-dose, up to 57 days after start of treatment
Number of patients with adverse events
Time frame: Up to day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FLOMAX® capsules and Ascending doses of HYTRIN® capsules in people with Prostatic Hyperplasia, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in American Urological Association (AUA) symptom score index (time frame: Pre-dose, up to day 57 after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.