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 Hypertension

A Phase III, Randomized, Double Blind, Parallel Group, Comparative Clinical Trial to Evaluate the safety, tolerability and efficacy of 2 Fixed dose combinations of Azelnidipine and Telmisartan when compared with fixed dose combination of Amlodipine and Telmisartan in patients with Stage II hypertension. - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022543

Enrollment

210

Registered

2019-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I159- Secondary hypertension, unspecified

Interventions

Intervention1: Azelnidipine 8 mg and Telmisartan 40 mg: Azelnidipine 8 mg and Telmisartan 40 mg 1 tablet to be taken daily, orally with plain water after meal, daily for 84 days. Intervention2: Azeln

Eligibility

Inclusion criteria

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 =100 to 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

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.

Design outcomes

Primary

Measure	Time frame
Primary objective: The Primary objective of this trial is to find out safety & tolerability of the product. Secondary Objective: The secondary objective of this trial is to find out efficacy of the investigational products.Timepoint: Visit 1 To Visit 6	—

Secondary

Measure	Time frame
1. Difference in mean change in SBP from baseline at the end of 12 weeks between each FDC group 2. Difference in mean change in DBP from baseline at the end of 12 weeks between each FDC group Timepoint: Visit 1 To Visit 6	—

Countries

India

Contacts

Public ContactDr Devesh Kumar

IR Innovate Research Private Limited

devesh.kumar@innovate-research.com9971169602

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026