Phase III clinical study to compare safety and efficacy of 2 Dosage of Telmisartan and Azelnidipine when compared to Telmisartan and Almlodipine in Patients with Stage II Hypertensio

Phase 3

Completed

• Conditions: Health Condition 1: I159- Secondary hypertension, unspecified

• Registration Number: CTRI/2019/12/022543
• Lead Sponsor: Synokem Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-06-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

1.Patients of either sex aged between 18 to 75 years

2.Signed written informed consent obtained prior to inclusion in the study.

3.Patient diagnosed with Stage II hypertension (SBP >=160 to <=180 and DBP >=100 to <=110 mmHg))

4.Subjects who are newly diagnosed with hypertension or Subjects who have not received anti-hypertensive medication for at least 2 weeks prior to Visit 1

5.Subjects willing to adhere to protocol and study requirements during the entire study duration

6.Subjects having no abnormalities in general physical examination

Exclusion Criteria

1.Not willing to sign the ICF.

2.Known or suspected secondary hypertension.

3.Mean SBP greater than 180 mmHg.

4.Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.

5.Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range).

6.Patients with the history of Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney.

7.Uncorrected volume or sodium depletion or hyponatremia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified