A comparative study with an objective to evaluate the efficacy and safety of a Single-pill combination of Cilnidipine 10 mg and Telmisartan 40 mg compared with Telmisartan 40 mg to explore the effects of the treatments on BP management and Renal outcomes in 200 Indian Diabetic hypertensive patients

Phase 4

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

• Registration Number: CTRI/2022/03/041486
• Lead Sponsor: JB Chemicals and Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

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

Inclusion Criteria

To be eligible to be enrolled into the study, subjects should fulfil the following criteria.

1.Male or female patients aged 40 â?? 75 years with a clinical diagnosis of hypertension with diabetes (treatment Naïve patients)

2.BP measures at baseline (outpatient systolic/diastolic BP >= 130/80 and < 180/110 mmHg)

3.Diabetes status: Type 2 diabetes HbA1c levels: >6.5%

4.Blood glucose levels (Fasting: >126 mg/dl, Post prandial: >160 mg/dl)

5.With Microalbuminuria (urinary albumin to creatinine [Cr] ratio [UACR] >= 30 and < 300 mg/g in spot urine)

6.eGFR: >90

7.Patients must be able to read, understand and follow study related documents/procedures and willing to provide written informed consent

Exclusion Criteria

To be eligible for the study, the below parameters should be ensured to be excluded:

Patients with Advanced renal disease (CKD stage 3,4,5, Serum creatinine: >3mg/dl), Severe hypertension (BP >=180/110mmHg, complicated hypertension (increased CV risk)

Elderly patients >75 years of age

Hypertensive emergency patients

Secondary hypertension.

Patients with history of Type I DM

Patients with history of liver and renal disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified