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Study Protocol: A Double blind placebo controlled, multi-center trial examining the effect of “LBP” on the patients with mild hypertension.

Objective

The objective of this study is to assess the efficacy of drug LBP is superior to placebo in the treatment of mild hypertension. This is a multi-center trial and will be taking place in different locations.

Outcome Measures for this Clinical Trial
Primary Outcome Measures:
Difference in mm Hg between the mean supine diastolic blood pressure (SDBP) as measured by office blood pressure (OBP) values the baseline period and the values at 0, 4, 7 and at the end of the treatment period which is 14 days..

Secondary Outcome Measures:
Change in mean systolic blood pressure (SSBP) at 0, 4, 7 and at 14 days weeks as measure by OBP.

Study Population
Eligibility:
Ages Eligible for Study:       18 years to 75 years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers: Yes

Criteria
Inclusion Criteria:
1. Mild-to-moderate hypertension defined as a mean supine diastolic blood pressure (SDBP) of greater than or equal to 95 mmHg and less than or equal to 109 mmHg, measured by manual cuff sphygmomanometer.

2. 24 hour mean SSBP of greater than or equal to 85 mmHg as measured by OBP.
3. Male and female patients 18 to 75 years of age.
4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator’s discretion).
5. Ability to provide written informed consent in accordance with GCP and local legislation.

Exclusion Criteria:
1. Recent history of MI, heart failure, unstable angina, coronary artery bypass graft, precutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
2.  Pregnant or breastfeeding women and women of fertile age who are not using safe contraceptive method or do not intend to use one during the trial.

Study Design:  Allocation: Randomized
                           Masking: Double Blind (Subject, Investigator)
                           Control: Placebo-controlled
                           Primary Purpose: Treatment
                          Intervention Model: Parallel Assignment

Study Type: Interventional

Treatment Group Specification and Assignment:

The double blind study design in which participants, staff, and study personnel will be double blinded to group enrollment will ensure that information collected is similar between the drug “LBP” and placebo groups. In order to have similar presentation and appearance of “LBP” and placebo, “LBP” tablets will be crushed and mixed with water. Participants will receive either “LBP” or placebo following randomization. Measured SDBP and SSBP will not be made available until the completion of the study period.

Objective:
The trial’s primary objective is to demonstrate that a one of the two chosen drugs “LBP” or Placebo is superior in the treatment of subjects with hypertension. The efficacy of the experimental drug will be evaluated using mean reduction from baseline at the end of day 14. The primary endpoint will be change from baseline in mean SDBP and the secondary endpoint will be SSBP.

The hypothesis we are interested for this trial will be: