Must make our own Phase 2 study; 8 pages and come up with a introduction, selection and withdrawal of subjects, assessment of safety and analysis

3. STUDY DESIGN

3.1. OVERALL DESIGN

This is a phase 2 study that seek to identify an acceptable dose and evaluate the efficacy, safety, tolerability, and pharmacokinetics of orally administered drug FK67T in human subjects for the treatment of the symptoms of atrial fibrillation. This drug (FK67T) has been shown to reduce the incidence of severe chest pain, severe tachycardia, and lowers blood pressure without the extreme fatigue, severe dizziness and bouts of depression associated with high dose metoprolol. Earlier studies demonstrated that 7.5 mg dose of FK67T given twice daily was as effective as 10 mg metoprolol given three times a day in a canine model of hypertension. This study is a randomized double blinded placebo control clinical trial that utilizes block randomization. Dose ranges from 7.5 mg to 37.5 mg and are given twice a daily to human subjects at a single site with an intension to treat.

3.2. SCIENTIFIC RATIONAL FOR STUDY DESIGN

FK67T has demonstrated efficacy in non-human subjects for the treatment of symptoms of atrial fibrillation. FK67T also demonstrated acceptable safety profile in healthy human subjects during a phase 1 clinical trial. The result of the phase 1 clinical trial informs the basis of dose parameters to be studied in phase 2 clinical trial. A dose of 40 mg of FK67T given twice a day had produced unacceptable side effects in animals during preclinical studies and in humans during phase 1 clinical trial. A two times daily dose of 10mg, 20 mg, and 30 mg will be evaluated for safety, efficacy, and tolerability in a placebo control trial. Only one of the three doses will be administered to each participant for the entire study duration. By utilizing a multi dose, randomized, double blinded, placebo control trial, the effectiveness, safety, and tolerability of FK67T can be evaluated for each respective dose. This also helps ensure that biases are eliminated to improve the quality and reliability of the data generated.

3.3. JUSTIFICATION FOR DOSE

The choice of 10 mg, 20 mg and 30 mg helps provide data that will help clinicians to evaluate the effectiveness, safety, and tolerability of drug FK67T at each respective dose compared to placebo. This helps in determining the most effective dose, minimal effective dose, and maximum effective dose. All three doses were chosen with an intension to avoid the 40 mg dose which had previously been shown to induce unacceptable side effects.

3.4. END OF STUDY DEFINITION

The duration of the clinical trial will be for 90 days and would be considered completed when participants are no longer being examined or the last study visit had occurred. A participant will be considered to have completed to the study if he/she had completed all aspects of the study including scheduled visits and procedures.