最新临床试验方案模板-2

最新临床试验方案模板-2内容摘要：

from Baseline in mean seated office cuff DBP (24177。 2 hours) at Week 6 or end of study. Secondary Endpoints: Confidential Page 7 of 35 Protocol: ABC01 Final  Change from Baseline in seated office systolic blood pressure (SBP) at Weeks 2, 4, 6 or end of study and DBP at Weeks 2 and 4 or end of study,  Change from Baseline to Week 6 or end of study in mean 24hour and mean daytime ambulatory DBP (time of dose until 8:00 PM) as measured by ABPM,  Change from Baseline to Week 6 or end of study in mean 24hour and mean daytime (time of dose until 8:00 PM) ambulatory SBP as determined by ABPM,  Proportion of patients with seated office cuff DBP reduced 4 mmHg from baseline at Week 6 or end of study,  Proportion of patients who are normalized by office BP measurements (defined as a trough seated SBP 135 mmHg and/or DBP 85 mmHg at Week 6 or end of study), and  Proportion of patients with a reduction in ambulatory mean 24hour DBP 10 mmHg from baseline at Week 6 or end of study. Safety Measures: Patient safety will be assessed by monitoring and reporting of adverse events (AE) that occur during the study. Further safety assessments will include physical examinations, 12lead electrocardiogram (ECG), and clinical laboratory tests. Statistical Analysis: Efficacy analyses will be conducted for two populations: Modified IntenttoTreat (ITT) and Per Protocol (PP). Descriptive statistics will be presented for the observed blood pressure values, but analysis will be performed on change from baseline. Change from baseline will be calculated as BPt – BP0 where BPt is defined as the blood pressure measurement obtained at time = t (Week 2, 4, or 6) and BP0 is the baseline blood pressure (Randomization, Week 0). The primary efficacy endpoint is the change from Baseline in mean seated office cuff DBP (24177。 2 hours) at Week 6 or end of study. The primary analysis is the parison of the two treatment groups using the ITT and PP populations. Secondary efficacy analyses will be conducted for the ITT and PP populations. In addition, analyses for change from baseline for the primary efficacy endpoint will be presented in both ITT and PP populations, examining the effect of race (Caucasian versus NonCaucasian), gender (male versus female), and age ( 65 years versus ≥65 years) at Week 6 or end of study. These subgroup analyses by demographics will be performed for the primary efficacy endpoint but not for the secondary efficacy endpoints. For analyses conducted on efficacy results obtained at the various scheduled visits, missing values in the ITT population will be imputed using the last observation carried forward (LOCF) method except for mean ambulatory SBP and DBP by ABPM. Confidential Page 8 of 35 Protocol: ABC01 Final Continuous efficacy endpoints (., change from baseline in seated and standing systolic and diastolic office blood pressures) will be pared across treatment groups using a fixedeffect twoway analysis of variance (ANOVA) with center and treatment as factors. Categorical response variables (., proportion of normalized patients with SBP 135 mmHg and/or DBP85 mmHg) will be pared using the CochranMantelHaenszel test stratified by center. Confidential Page 9 of 35 Protocol: ABC01 Final 2. Background Information Background placeholder Study Rationale placeholder Toxicity and Preclinical experience placeholder Clinical experience placeholder Summary of Potential Risks and Benefits placeholder Confidential Page 10 of 35 Protocol: ABC01 Final 3. Study Objectives The objective of this study is to evaluate the safety and effectiveness of Drug A 20 mg once daily versus placebo using 24hour Ambulatory Blood Pressure Monitoring (ABPM) in patients with mild to moderate hypertension. Primary objectives The primary objective of the study is to pare the antihypertensive effectiveness using change from Baseline in mean seated office cuff diastolic blood pressure of Drug A 20 mg once daily to placebo. Secondary objectives The secondary objective is to evaluate the safety of lowdose Drug A pared to placebo and change from Baseline at Week 6 or end of study in mean 24hour and mean daytime ambulatory DBP (from time of dosing until 8:00PM) as measured by ABPM. Confidential Page 11 of 35 Protocol: ABC01 Final Study Design Study Endpoints Efficacy Endpoints see the protocol synopsis Safety Endpoints see the protocol synopsis Overall Study Design The study is a phase III, prospective, randomized, doubleblind, placebocontrolled clinical trial to evaluate the safety and effectiveness of Drug A 20 mg once daily versus placebo using 24hour Ambulatory Blood Pressure Monitoring (ABPM) in patients with mild to moderate hypertension. The study includes a 3 to 4week singleblind placebo runin phase and a 6week doubleblind treatment phase. The study will receive approval from the institutional review board (IRB)/ethics mittee (EC) at each site and will be conducted in accordance with the principles outlined in the Declaration of Helsinki. Written informed consent will be obtained from all subjects. This study will be at 20 sites in Europe, North America and Asian Pacific. Randomization/Blinding Procedure A centralized, centerblocked randomization procedure will be used for treatment assignment by means of an Interactive Voice Response System (IVRS). Subjects will be randomized 1:1 into 2 groups (Drag A n=90, placebo n=90). Subjects and study personnel will be blinded to treatment groups (active study drug vs. placebo). Stopping Rules Subject Withdrawal A subject (or subject39。 s legal guardian) is free to withdraw consent and discontinue p。