An Open-label, Randomized, Multicenter, Post-marketing study comparing the Effectiveness and Safety of Telmisartan plus Amlodipine with Telmisartan plus Cilnidipine in subjects with Hypertension and Renal Impairment.

Not Applicable

Completed

Conditions: Essential (primary) hypertension,

Registration Number: CTRI/2023/03/051014

Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary: A Prospective, Open-label, Randomized, Multicenter, Post-marketing study comparing the Effectiveness and Safety of Telmisartan plus Amlodipine with Telmisartan plus Cilnidipine in subjects with Hypertension and Renal Impairment.

Hypertension (HTN) is a public health menace contributing to up to 45% of cardiovascular disease (CVD) deaths and 51% of stroke deaths. In India, up to 33% of the urban and 25% of the rural population are afflicted with the disease.

Attainment of blood pressure (BP) goals in the population at large is a major challenge and area of focus of health systems worldwide. Over the years, BP targets have been continuously redefined as the armamentarium of drugs has expanded. The recently published the American College of Cardiology/American Heart Association (ACC/AHA) 2017 HTN guidelines advocate a paradigm shift in the way we manage abnormal BP

This is a Prospective, Open-label, Randomized, Multicenter, Post-marketing study comparing the Effectiveness and Safety of Telmisartan plus Amlodipine with Telmisartan plus Cilnidipine in subjects with Hypertension and Renal Impairment. 188 subjects (94 in each group) will be randomized in this study across 6 centers across India. The treatment duration of each subject will be 52 weeks. Change in UACR from baseline till Week 52 will be primarily evaluated. Change in eGFR, office blood pressure, serum creatinine levels, and serum uric acid levels will be evaluated as a secondary endpoint.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 188

Inclusion Criteria

Male or female subjects aged between 18 to 75 years 2.
Subjects with the ability to understand and provide written informed consent forms which must have been obtained prior to screening.
Subjects with hypertension (systolic/diastolic BP more than or equal to 130/80 and less than 180/110 mmHg 4.
Subjects with hypertension and renal impairment eGFR more than or equal to 60 ml/min/1.73m2 and urinary albumin in the range of 30â€“600 mg/g creatinine 5.
Subjects with hypertension requiring antihypertensive treatment with two drug therapy 6.
Subjects on a stable dose of antihypertensive treatment with Telmisartan for more than or equal to 3 months before the enrolment; 7.
Subjects not on CCB treatment for their hypertension management for more than or equal to 3 months before the enrolment 8.
Subjects willing to comply with the protocol requirements.

Exclusion Criteria

Presence of any clinically relevant disease/disorder (e.g., severe hepatic impairment, chronic renal failure, thromboembolic disorders, coronary artery or cerebrovascular diseases, uncontrolled diabetes (HbA1c more than or equal to 7%), uncontrolled thyroid disorder etc.) 2.
Causes of renal disease other than hypertension or T2DM 3.
Urinary tract infections 4.
Acute Kidney Injury (AKI) 5.
Subjects of T1DM 6.
Subjects of T2DM diagnosed more than 1 year prior to screening 7.
Severe hypertension (more than or equal to 180/110 mmHg) 8.
Serum creatinine more than or equal to 2.0 mg/dL in men or more than or equal to1.5 mg/dL in women 9.
Subjects, in the opinion of investigators, requiring initiation of treatment with initial monotherapy 10.
Surgical or medical condition that, in the judgment of the Investigator, could interfere with the absorption, distribution, metabolism, or excretion of the drugs to be used.
Presence or history of secondary or malignant hypertension.
Any known cardiac disease/disorder in which any of the study medications is contra-indicated.
Current or recent substance abuse, including alcohol.
Refusal or inability to comply with the requirements of the protocol for any the reason, including scheduled clinic visits and laboratory tests.
Participation in any experimental drug study within 60 days before screening.
Breast feeding or pregnant females or Females with child-bearing potential who do not follow adequate contraceptive measures.
Concomitant or prior (within 60 days of screening) use of any of the following medications: calcium channel blocker, clonidine, aliskerin.
Subjects having intolerance, hypersensitivity or any other contraindication to any of the Investigational products.
History of HIV, Hepatitis B and Hepatitis C.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in urinary	Time Frame: Day 0, Day 180 & Day 365
albumin-creatinine ratio (UACR)	Time Frame: Day 0, Day 180 & Day 365

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare the effect of Telmisartan plus Amlodipine Vs. Telmisartan	plus Cilnidipine in subjects suffering from hypertension and renal impairment by the-

Trial Locations

Locations (6): College of Medicine & J.N.M. Hospital
🇮🇳
Nadia, WEST BENGAL, India
Gillurkar Multispeciality Hospital
🇮🇳
Nagpur, MAHARASHTRA, India
MV Hospital & Research Center
🇮🇳
Lucknow, UTTAR PRADESH, India
Panchsheel Hospital Pvt. Ltd.
🇮🇳
East, DELHI, India
Santosh Hospital
🇮🇳
Bangalore, KARNATAKA, India
Udyan Health Care Pvt. Ltd.
🇮🇳
Lucknow, UTTAR PRADESH, India
College of Medicine & J.N.M. Hospital
🇮🇳Nadia, WEST BENGAL, India
Dr Chinmoy Barik
Principal investigator
9830290854
chinmoybk@gmail.com