A clinical trial to evaluate the efficacy and safety of FDC of Azelnidipine and Telmisartan ascompared to FDC of Amlodipine and Telmisartan in Indian Essential Hypertensive Patients

Phase 4

Not yet recruiting

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

• Registration Number: CTRI/2023/07/055818
• Lead Sponsor: Dr Akshay Ashok Bafna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

I. Patients of either sex aged between 18 to 75years (both

inclusive)

II. Treatment Naïve hypertensive patients with stage

II hypertension or patients who are not controlled on Telmisartan monotherapy (40 mg) with Stage I or II hypertension

III. Patients willing to provide written informed consent and comply with

the protocol requirements

IV. Subjects having no abnormalities in general physical examination

Exclusion Criteria

1. Patients with severe hypertension (defined as a DBP ?120 mmHg

or SBP ?180 mmHg)

2. Patients with suspected secondary hypertension, heart failure &

diagnosed cardiovascular diseases, new cerebrovascular diseases,

3. Patients using any other concomitant medications known to affect

BP or medication prohibited as per protocol.

4. Known hypersensitivity or allergy to calcium channel blockers and

angiotensin receptor blockers

5. Patients with the history of Bilateral renal artery stenosis, renal

artery stenosis

in a solitary kidney, patient postâ??renal transplant or with only one

functioning

kidney

6. Patients with history of any other clinically significant uncontrolled

systemic

diseases such as pulmonary, renal, neurological, psychiatric,

gastrointestinal,

metabolic, endocrine (uncontrolled diabetes mellitus), immunological

or

hematological disorders or malignancy

7. Pregnant or Lactating females; or female patients of childbearing

potential

unwilling to use effective contraception

8. Those who smoke >1 pack of cigarettes per day

9. Patients with continuing history of alcohol and/or drug abuse

10. Participation in another clinical trial within 3 months prior to

screening

11. Any other reason for which the investigator feels that the patient

should not

participate

Study & Design

• Study Type: PMS
• Study Design: Not specified