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CASE RECORD FORM

STUDY TITLE A prospective study to compare the efficacy and safety between two antihypertensive agents Olmesartan (20mg) and Amlodipine (5mg) in mild to moderate group of Hypertension patients.

Subject Initials: Subject No: Address: Life care Institute of Medical Science and Research (Ahmedabad) Investigators Name: Dr. Dushyant Balat (M.D. Medicine) Protocol Id: Protocol version no:

Confidentiality Statement All the information of the study subjects will be kept confidential and managed according to the requirements of the investigators and the Ethics committee of the Life care hospital.

Subject Id:

VISIT-1 (SCREENING VISIT) 1.0 PATIENTS DEMOGRAPHIC DATA Allocation to study treatment: Olmesartan 20mg Amlodipine 5mg

Date of Birth (dd/mm/yyyy): Screening Date (dd/mm/yyyy): Age (years): __ __ Gender: Male Female Weight: __ __ __ __ ( kg) Not Obtained

Height: __ __ __ __ (cm) Not Obtained

Body Mass Index (BMI): __ __ __ __ Kg/m2 Vital signs: Blood Pressure: __ __ __ / __ __ __ (Systolic BP /Diastolic BP) (mm Hg) Pulse rate: __ __ __ (Beats/min)

Food habit: Vegetarian Smoking History: Smoker

Non-Vegetarian Non-Smoker

Did the patient sign the informed consent form? Yes No

Date of signing informed consent (dd/mm/yyyy):

Signature of Study coordinator: ___________________

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Subject Id:

1.2 INCLUSION CRITERIA: (Note: All the inclusion Criteria should be marked as Yes and if it is tick marked as No then the subject will not be included in the study) Sr No Criteria Yes 1) Is the subject willingly able to give the informed consent? 2) 3) The Subjects age limit is between 18-75 years The subject must have mean sitting diastolic blood pressure >= 90 mmHg and mean sitting systolic blood pressure >= 140 mmHg The subject who has any history of renal failure can be included in this study. The subjects who are suffering from co morbid conditions like Diabetes Mellitus and Ischemic heart disease (IHD) can be included in this study. No N/A

4) 5)

1.3 EXCLUSION CRITERIA: (Note: All the exclusion Criteria should be marked as No and if it is tick marked as Yes then the subject will not be included in the study) Sr No 1) 2) 3) Criteria Yes Is the subject having any previous history of AntiHypertensive treatment? Has the subject undergone CHA, CABG, and PTCA within last 3 months? Pregnant women or the women who are likely to become pregnant No N/A

Did the patient fulfill all the eligibility criteria? Yes No

If no then please mention the reason: ______________________________________________________________________________ ______________________________________________________________________________

Signature of the Investigator: ________________________________


Signature of Study coordinator: ___________________

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Subject Id:

1.4 Hypertension History: Newly Diagnosed? YES NO

Severity of Hypertension: Stage 1(prehypertension)


Category Systolic pressure(mm HG) Normal Pre hypertension Less than 120 120-139 and or Hypertension Stage- 1 Stage- 2 140-159 (mild group) or 90-99 100 or higher

Stage 2
blood

Stage 3
Diastolic blood

pressure (mm Hg) Less than 80 80-89

160 or higher (moderate or group)

(Each hypertension stage (as determined in 2003 by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7), a team of experts assembled by the National Heart, Blood, and Lung Institute) is based on an average of two or more seated blood pressure readings completed in two or more office visits. The JNC7 condensed the previous three hypertension stages into two and created a broader hypertension stage identified now as hypertension stage 1 and 2)

Signature of Study coordinator: ___________________

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Subject Id:

1.5 LABORATORY INVESTIGATIONS: Parameter Serum Creatinine Serum Potassium Serum Sodium Blood Sugar Total Cholesterol LDL(Low density lipo-protein) HDL(High density lipo-protein) Triglycerides Observed Value Normal Value 0.6-1.5 mg/dl 3.7-5.5 mEq/l 137-145 millimoles/l 70-110 mg/dl 150-200 mg/dl 80-150 mg/dl 30-60 mg/dl 35-135 mg/dl

1.6 CONCOMITANT ILLNESS: Sr no.

YES

NO Condition

NONE

Signature of the Investigator: _________________________________________

Signature of Study coordinator: ___________________

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Subject Id:

1.7 CONCOMITANT MEDICATIONS: Sr no. Drug (Generic name) Dose

Yes

No

NONE Current status

Reason for therapy

VISIT 2: (ENROLLMENT VISIT) Allocation to study treatment: Olmesartan 20mg Amlodipine 5mg Yes No No No

Does the patient meet selection criteria?

Is the patient complaint to the study treatment? Yes Verified written Informed consent Yes

Date (dd/mm/yyyy ): __ __/__ __ / __ __ __ __ Vital signs: Blood Pressure: __ __ __ / __ __ __ (Systolic BP /Diastolic BP) (mm Hg) Pulse rate: __ __ __ (Beats/min) YES Adverse Events: ( If any adverse event is noted) NO

If yes please specify: _____________________________________________________________


Signature of Study coordinator: ___________________

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Subject Id:

Blood Pressure controlled (SBP < 140 & DBP < 90) Here mention the reduction in blood pressure after taking the medication after visit-1 YES NO

If yes then the Blood Pressure observed in this visit is __ __ __ / __ __ __ (Systolic/Diastolic mmHg) If no then what measures are taken: ______ 2.0 LABORATORY INVESTIGATIONS: Parameter Serum Creatinine Serum Potassium Serum Sodium Blood Sugar Total Cholesterol LDL(Low density lipo-protein) HDL(High density lipo-protein) Triglyceride Observed Value Normal Value 0.6-1.5 mg/dl 3.7-5.5 mEq/l 137-145 millimoles/l 70-110 mg/dl 150-200 mg/dl 80-150 mg/dl 30-60 mg/dl 35-135 mg/dl

Signature of Study coordinator: ___________________

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Subject Id:

2.1 CONCOMITANT MEDICATIONS: Sr no. Drug (Generic name) Dose

Yes Reason for therapy

No

NONE Current status

EFFICACY EVALUATION: Did the subject get benefitted through the medication? Yes No

SAFETY EVALUATION: No

Did the subject have any adverse event reported during the treatment? Yes

Signature of the Investigator: ______________________________________

VISIT 3: FOLLOW UP VISIT Allocation to study treatment: Olmesartan 20mg Amlodipine 5mg

Date: (DD/MM/YYYY) __ __/__ __ / __ __ __ __ Vital signs: Blood Pressure: __ __ __ / __ __ __ (Systolic BP /Diastolic BP) (mm Hg) Pulse rate: __ __ __ (Beats/min) Adverse Events: NO
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YES

Signature of Study coordinator: ___________________

Subject Id:

If yes please specify: _____________________________________________________________ Blood Pressure controlled (SBP < 140 & DBP < 90) Here mention the reduction in blood pressure after taking the medication after visit-2 YES NO

If yes then the Blood Pressure observed in this visit is __ __ __ / __ __ __ (Systolic/Diastolic mmHg) If no then what measures are taken: ______ 3.0 LABORATORY INVESTIGATIONS: Parameter Serum Creatinine Serum Potassium Serum Sodium Blood Sugar Total Cholesterol LDL(Low density lipo-protein) HDL(High density lipo-protein) Triglyceride Observed Value Normal Value 0.6-1.5 mg/dl 3.7-5.5 mEq/l 137-145 millimoles/l 70-110 mg/dl 150-200 mg/dl 80-150 mg/dl 30-60 mg/dl 35-135 mg/dl

Signature of Study coordinator: ___________________

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Subject Id:

3.1 CONCOMITANT MEDICATIONS: Sr no. Drug (Generic name) Dose Reason for therapy

NONE Current status

EFFICACY EVALUATION: No

Did the subject get benefitted through the medication? Yes SAFETY EVALUATION:

Did the subject have any adverse event reported during the treatment? Yes

No

Signature of the Investigator: _____________________________________________

Signature of Study coordinator: ___________________

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