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

"A prospective, single centre, double-blinded, randomised trial with an objective to evaluate the efficacy and safety of an SPC of Cilnidipine (10mg) + Telmisartan (40mg) compared to Telmisartan (40mg) and explore the effects of the SPC on renal outcomes in 200 Indian Diabetic hypertensive patients. The study drug will be Cilacar T (10/40)"

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041486

Enrollment

200

Registered

2022-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: Cilnidipine 10mg and Telmisartan 40mg tablets: Cilnidipine 10mg and Telmisartan 40mg orally once daily for 365 consecutive days Control Intervention1: Telmisartan 40mg: Telmisartan (40m

Eligibility

Inclusion criteria

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 NaÃ¯ve patients) 2. BP measures at baseline (outpatient systolic/diastolic BP >= 130/80 and 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 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

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.

Design outcomes

Primary

Measure	Time frame
Efficacy: Reduction in blood pressure (Home and Office) to a target of â?¤140/90 (Standard BP Control) Timepoint: Study duration: 1 year Assessment: Every 3 months	—

Secondary

Measure	Time frame
The improvement in renal parameters â?? urinary albumin / protein excretion (UACR), renal function from baseline (Change in mg/g UACR from baseline to end of study period) Other parameters to be monitored: Pedal edema, diabetic control, heart rate/pulse rate to be monitored Please revert to any cardiovascular outcomes such as incidences of Death, myocardial infarction, stroke, hospitalisation with heart failure Timepoint: Trial duration: 1 year Assessment: every 3 months	—

Measure

Time frame

The improvement in renal parameters â?? urinary albumin / protein excretion (UACR), renal function from baseline (Change in mg/g UACR from baseline to end of study period) Other parameters to be monitored: Pedal edema, diabetic control, heart rate/pulse rate to be monitored Please revert to any cardiovascular outcomes such as incidences of Death, myocardial infarction, stroke, hospitalisation with heart failure Timepoint: Trial duration: 1 year Assessment: every 3 months

—

Countries

India

Contacts

Public ContactDr Rajesh Thachathodiyl

Amrita Institute of Medical Sciences, Kochi

drtrajesh@aims.amrita.edu9895028709

Outcome results

None listed

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