chapter seven
Below is a detailed chart showing when the testing and safety measurements were taken beginning with Day 1 that includes IPSS, URF, Prostate Volume and PSA. After taking UMOOZE ® twice daily, IPSS and URF tests were done as a safety measurement. Day 42 involved an IPSS followed by a complete lab test for vital signs that included the same tests from Day 1: IPSS, URF, Prostate Volume and PSA.
Results The results of the study were recorded as follows:
• Improved the mean change from baseline in IPSS at Day 28( visit 4, all patients).
• Improved the mean change from baseline in IPSS at Day 28( visit 4, patients who fit Qmax≤15mL / sec criteria).
• Improved the mean change from baseline in IPSS at Day 28( visit 4, patients took BPH drug less than 6 months, p≤0.05).
• Improved the mean change from baseline in IPSS at Day 28( visit 4, patients took Harnalidge 0.4mg once daily for up to 6 months, p≤0.05).
• Improved the mean change from baseline in IPSS at Day 28( visit 4, patients with non-Harnalidge 0.4mg treatment).
• Improved nocturia in patients with Qmax≤15mL / sec at any stages of the study.
• Improved the mean change from baseline in QoL at Day 56( visit 6, patients who fit IPSS criteria).
• Improved the mean change from baseline in QoL at Day 56( visit 6, patients took Harnalidge 0.4mg once daily, p≤0.05).
• Improved the mean change from baseline in QoL at Day 56( visit 6, patients took Harnalidge 0.4mg once daily and fit IPSS criteria, p≤0.05).
• Improved the mean change from baseline in QoL at Day 56( visit 6, patients took Harnalidge 0.4mg once daily and fit Qmax criteria).
• Improved the mean change from baseline in QoL at Day 42( visit 5, patients took Harnalidge 0.4mg once daily).
• Improved the mean change from baseline in QoL at Day 42( visit 6, patients took Harnalidge 0.4mg once daily and fit both Qmax≤15mL / sec and IPSS criteria).
• Improved the mean change from baseline in PVR at Day 56( visit 6, all patients, p≤0.05).
• Improved the mean change from baseline in PVR at Day 56
44