To Evaluate the Efficacy and Safety of Moxonidine tablets in Patients with Uncontrolled Hypertension

Not yet recruiting

• Conditions: Hypertensive heart disease, (2) ICD-10 Condition: I10||Essential (primary) hypertension,

• Registration Number: CTRI/2020/12/029503
• Lead Sponsor: Dr Atul Rajkondawar

Brief Summary

This study is a randomized, parallel-group, open-label study with two study treatment groups: Group A (Moxonidine tablets–(0.2 mg and/or 0.3 mg tablets)– and Group B (FDC tablet of Amlodipine 5 mg +Telmisartan 40 mg + Chlorthalidone 12.5 mg). The total enrolled sample size will be 40 patients. The patients will be assigned treatment from anyone group–Group A or Group B as per a predetermined randomization schedule in a 1:1 ratio. The randomization schedule will be generated by a statistician using the SAS program. Primary Efficacy Objective of the study is to evaluate the efficacy of investigational products in patients with uncontrolled hypertension on Day 57 (±4 days) of treatment as assessed by change from baseline in sitting SBP and DBP. The study will be conducted at one study site. The total study duration per patient is approx two months & there will be a total of five visits–four study site visits (Visit 1 to Visit 4) and one telephonic safety visit (Visit 5). Telephonic contacts will also be conducted during the first seven days of the treatment period and on Day 14 (±2 days) and Day 35 (±2 days) during the treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-12
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult male or female patients between 18 to 65 years (both ages inclusive) 2.
• Patients with uncontrolled hypertension receiving stable dose of three drug combination of Amlodipine 5 mg + Telmisartan 40 mg + Chlorthalidone 12.5 mg in a fixed dose combination for at least 6 weeks prior to randomization and who require treatment with Moxonidine based on investigator’s discretion 3.
• Patients willing to give their written informed consent to participate in the study 4.
• Patients willing to comply with all aspects of the protocol.

Exclusion Criteria

• 1.Patients with seated systolic blood pressure more than or equal to 180 mmHg and/or diastolic blood pressure more than or equal to 110 mmHg 2.Patients hypersensitive to active or inactive ingredients of investigational products 3.Patients with uncontrolled diabetes mellitus at screening 4.Apparent/pseudo resistant hypertension due to white coat effect, medical inertia, poor therapeutic adherence, or history of secondary causes of hypertension 5.Currently receiving beta-blocker as one of the antihypertensive agents or has received beta-blocker in past 6 months prior to screening 6.Currently receiving or received in 6 months prior to screening alpha adrenoreceptor, imidazole receptor or any other centrally acting drugs as part of antihypertensive drug 7.Patients with predisposition to atrioventricular block, or known history of symptomatic hypotension or orthostatic hypotension, clinically significant electrolyte imbalance 8.Patients with serum creatinine more than 1.8 mg/dL 9.Female patients who are pregnant, lactating, or planning to become pregnant.
• 10.Female patients not willing to use acceptable method of contraception 11.Patients receiving tricyclic antidepressants, benzodiazepine or have received within the past month prior to screening and systemic steroids, thyroid hormones, oral contraceptives, antipsychotic drugs, nonsteroidal antiinflammatory drugs (NSAIDs), sympathomimetics, immunosuppressants, etc.
• have been continuously administered for more than 12 weeks prior to visit 1 (screening) 12.History of clinically significant hematologic, hepatic, biliary obstructive disorders, neurologic (including extra pyramidal disorder), psychiatric, renal, cardiovascular (e.g. heart failure, bradycardia [resting heart rate <50 beats per minute], severe bradyarrythmia, sick-sinus syndrome, atrioventricular block, malignant arrhythmia, severe coronary artery disease, unstable angina, vascular heart disease), endocrine, or other diseases that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses if the disease exacerbates during the study 13.Patients scheduled/expected to undergo surgery during the study period 14.Patients who have received any intervention in a clinical trial within 3 months prior to screening 15.Patients with history of alcohol and/or drug/substance abuse & current significant alcohol consumption which as per PI judgment, make the patient ineligible to participate in the study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in sitting SBP and DBP on Day 57 (±4 days) in both treatment groups.	Day 57 (±4 days)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in sitting SBP and DBP on Day 28 (±4 days) in both treatment groups	Proportion of patients achieving goal BP during the study in both treatment groups

Trial Locations

Locations (1)

Meditrina Institute of Medical Sciences; 🇮🇳 Nagpur, MAHARASHTRA, India

Meditrina Institute of Medical Sciences

🇮🇳Nagpur, MAHARASHTRA, India

Dr Atul Rajkondawar

Principal investigator

9373215775

atul.rajkondawar@gmail.com