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CTRI Number  CTRI/2020/12/029503 [Registered on: 02/12/2020] Trial Registered Prospectively
Last Modified On: 27/11/2020
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Evaluate the Efficacy and Safety of Moxonidine tablets in Patients with Uncontrolled Hypertension 
Scientific Title of Study   A Prospective,Randomized, Open-label,Investigator initiated Study to Evaluate the Efficacy and Safety of Moxonidine tablets versus Fixed Dose Combination of Amlodipine 5 mg ,Telmisartan 40 mg & Chlorthalidone 12.5 mg Tablets in Patients with Uncontrolled Hypertension 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-021-MOXO-2020_Version 2.0/30-Sep-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atul Rajkondawar 
Designation  Consultant Physician and Director of Medical Service 
Affiliation  Meditrina Institute of Medical Sciences 
Address  Meditrina Institute of Medical Sciences,room no.01 , Research department, 278 Central Bazar Road Ramdaspeth.

Nagpur
MAHARASHTRA
440010
India 
Phone  9373215775  
Fax    
Email  atul.rajkondawar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Atul Rajkondawar 
Designation  Consultant Physician and Director of Medical Service 
Affiliation  Meditrina Institute of Medical Sciences 
Address  Meditrina Institute of Medical Sciences, Room No.01 , Research department . 278 Central Bazar Road Ramdaspeth

Nagpur
MAHARASHTRA
440010
India 
Phone  9373215775  
Fax    
Email  atul.rajkondawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Atul Rajkondawar 
Designation  Consultant Physician and Director of Medical Service 
Affiliation  Meditrina Institute of Medical Sciences 
Address  Meditrina Institute of Medical Sciences, Room No.01 , Research department 278 Central Bazar Road Ramdaspeth

Nagpur
MAHARASHTRA
440010
India 
Phone  9373215775  
Fax    
Email  atul.rajkondawar@gmail.com  
 
Source of Monetary or Material Support  
MACLEODS PHARMACEUTICALS LTD. R & D III, Plot No. 18, Street No. 9, MIDC Area Andheri-(East), Mumbai 400 093, India. Tel.: 91-22-48890100 
 
Primary Sponsor  
Name  Dr Atul Rajkondawar 
Address  Meditrina Institute of Medical Sciences 278 Central Bazar Road Ramdaspeth Nagpur Maharashtra 440010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Rajkondawar  Meditrina Institute of Medical Sciences  Room No.01 , Research department,278 Central Bazar Road Ramdaspeth 440010 India
Nagpur
MAHARASHTRA 		 9373215775

atul.rajkondawar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medrina Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I11||Hypertensive heart disease, (2) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Moxonidine Tablet  Dose-Treatment to be initiated at 0.3 mg per day in the morning. If the blood pressure remains uncontrolled or increases from baseline, the dose will be increased after three weeks to 0.4 mg, 0.5 mg, or 0.6 mg per day based on PI’s discretion. The increased dose will be given as divided doses in the morning and evening. A single dose of 0.4 mg moxonidine and a daily dose of 0.6 mg per day should not be exceeded. Route Of Administration-Oral Duration Of Therapy-56 Days 
Comparator Agent  TELMA ACT 40/5/12.5MG TAB   Dose-FDC tablet of Amlodipine 5 mg+ Telmisartan 40 mg+ Chlorthalidone 12.5 mg Frequency-Once daily in the morning Route Of Administration-Oral With or without food Therapy- 56 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. 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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in sitting SBP and DBP on Day 57 (±4 days) in both treatment groups.  Day 57 (±4 days) 
 
Secondary Outcome  
Outcome  TimePoints 
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 		 Day 28 (±4 days) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.





 
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