【正文】 nitrates or other vasodilators。 Confidential Page 1 of 35 Protocol: ABC01 Final CLINICAL PROTOCOL Sponsor Name Best Pharmaceutical, Inc Protocol Title MultiCenter, Randomized, DoubleBlind, PlaceboControlled Study Comparing the Safety and Effectiveness of Drug A 20 mg Once Daily Versus Placebo Using 24Hour Ambulatory Blood Pressure Monitoring In Patients With mild to moderate Protocol Number ABC01 Protocol Date 27March2020 Version Number Final Amendment Number 0 IND Number 999,999 NDA Number Not applicable Primary Author Best Protocol Author, MD Contributing Authors Best SAP Author, PhD Best CSR Author, MD Drug Name Drug A Phase of Development III Indication Mild to moderate hypertension Study Sponsor: Best Pharmaceutical, Inc. Wonderful Road, Suite 909 Rockville, MA 20850 Phone: 9999999999 Fax: 9999998888 Web: CONFIDENTIAL This document is a confidential munication of the Sponsor. Acceptance of this document constitutes the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. Confidential Page 2 of 35 Protocol: ABC01 Final Protocol Signature Page Best Pharmaceutical, Inc Protocol ABC01 Original Approval Date: March XX, 2020 A MultiCenter, Randomized, DoubleBlind, PlaceboControlled Study Comparing 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 Protocol Final Version Approval This protocol has been verified and approved by: _____________________________________________ __________________ name and degree Date title pany ______________________________________________ __________________ name and degree Date title pany ______________________________________________ __________________ name and degree Date title pany Confidential Page 3 of 35 Protocol: ABC01 Final TABLE OF CONTENTS Protocol Signature Page ...................................................................................................... 2 List of Abbreviations .......................................................................................................... 5 1. PROTOCOL SYNOPSIS ................................................................................................ 6 2. Background Information ................................................................................................. 9 Background .......................................................................................................... 9 Study Rationale ..................................................................................................... 9 Toxicity and Preclinical experience ......................................................................... 9 Clinical experience ................................................................................................ 9 Summary of Potential Risks and Benefits.................................................................. 9 3. Study Objectives .......................................................................................................... 10 Primary objectives ............................................................................................... 10 Secondary objectives............................................................................................ 10 Study Design ..............................................................................................................11 Study Endpoints ...................................................................................................11 Overall Study Design ............................................................................................11 Randomization/Blinding Procedure.........................................................................11 Stopping Rules .....................................................................................................11 Maintenance of Randomization Codes and Procedure for Breaking Codes .................. 12 Study Population ........................................................................................................ 14 Inclusion Criteria ................................................................................................. 14 Exclusion Criteria ................................................................................................ 14 Investigational Medicine Products ................................................................................ 16 Study Treatment .................................................................................................. 16 Conitant Medications and Prohibited Medications.............................................. 16 Study Procedures ........................................................................................................ 18 Visit 1 (Week 4, Screening).................................................................................. 18 Visit 2 (Week 3, Placebo Runin) .......................................................................... 18 Visit 3 (Week 2, Placebo Runin) .......................................................................... 19 Visit 4 (Week 1, Placebo Runin) .......................................................................... 19 Visit 5 (Week 0 Baseline) or Visit 4A (Week 1A Placebo RunIn) ............................. 19 Visit 6 (Week 0, Baseline/Randomization) .............................................................. 20 Visit 7 (Week 2, DoubleBlind Treatment) .............................................................. 20 Visit 8