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Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

Primary Purpose

Prostatic Hyperplasia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Tamsulosin

UK-369,003

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring With or without erectile dysfunction

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13
Clinical diagnosis of BPH.
Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening).

Exclusion Criteria:

Urinary tract infection
Primary neurological conditions affecting bladder function

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Comparator

Treatment Arm

Arm Description

Tamsulosin 0.4 mg prolonged release

There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg & 100mg), UK-369,003 IR (40mg),

Outcomes

Primary Outcome Measures

Change in international prostate symptom score

Secondary Outcome Measures

Erectile Function (EF) domain of International Index of Erectile

Function (IIEF)

Qmax

Quality of Erection questionnaire (QEQ)

Population pharmacokinetics

Full Information

NCT ID

NCT00457457

First Posted

April 5, 2007

Last Updated

December 16, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00457457

Brief Title

Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

Official Title

A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Proof of Concept and Dose Ranging Study With an Active Control to Assess the Efficacy and Safety/Tolerability of UK-369,003 Immediate Release (IR) and Modified Release (MR) in the Treatment of Men With Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Hyperplasia

Keywords

With or without erectile dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

609 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

Tamsulosin 0.4 mg prolonged release

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg & 100mg), UK-369,003 IR (40mg),

Intervention Type

Drug

Intervention Name(s)

Tamsulosin

Intervention Description

Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate

Intervention Type

Drug

Intervention Name(s)

UK-369,003

Intervention Description

UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (>80 fold) compared to sildenafil (~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED

Primary Outcome Measure Information:

Title

Change in international prostate symptom score

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Erectile Function (EF) domain of International Index of Erectile

Time Frame

12 weeks

Title

Function (IIEF)

Time Frame

12 weeks

Title

Qmax

Time Frame

12 weeks

Title

Quality of Erection questionnaire (QEQ)

Time Frame

12 weeks

Title

Population pharmacokinetics

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13 Clinical diagnosis of BPH. Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening). Exclusion Criteria: Urinary tract infection Primary neurological conditions affecting bladder function

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Herston

State/Province

Queensland

Country

Australia

Facility Name

Pfizer Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Pfizer Investigational Site

City

Brussels

ZIP/Postal Code

B-1090

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Brussels

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Edegem

ZIP/Postal Code

B-2650

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2V 4R6

Country

Canada

Facility Name

Pfizer Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Temuco

State/Province

IX Region

ZIP/Postal Code

4810371

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

Country

Chile

Facility Name

Pfizer Investigational Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Gentofte

ZIP/Postal Code

2820

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Kuopio

ZIP/Postal Code

70100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Oulu

ZIP/Postal Code

90100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Pfizer Investigational Site

City

Rio

ZIP/Postal Code

26500

Country

Greece

Facility Name

Pfizer Investigational Site

City

Thessaloniki

ZIP/Postal Code

56403

Country

Greece

Facility Name

Pfizer Investigational Site

City

Foggia

ZIP/Postal Code

71100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Pfizer Investigational Site

City

Kaunas

ZIP/Postal Code

47144

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Vilnius

ZIP/Postal Code

08661

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-092

Country

Poland

Facility Name

Pfizer Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Pfizer Investigational Site

City

Gdansk

ZIP/Postal Code

80-402

Country

Poland

Facility Name

Pfizer Investigational Site

City

Gdynia

ZIP/Postal Code

81-393

Country

Poland

Facility Name

Pfizer Investigational Site

City

Myslowice

ZIP/Postal Code

41-400

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wejherowo

ZIP/Postal Code

84-200

Country

Poland

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Malacky

ZIP/Postal Code

901 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Prešov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Skalica

ZIP/Postal Code

909 82

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28035

Country

Spain

Facility Name

Pfizer Investigational Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Pfizer Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711044&StudyName=Study%20the%20effects%20of%20different%20doses%20of%20UK-369%2C003%20in%20men%20with%20lower%20urinary%20tract%20symptoms.%20%20

Description

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Learn more about this trial

Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

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Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

Prostatic Hyperplasia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial