A clinical trial to study the effects of three drugs, Olmesartan Medoxomil, Chlorthalidone and Cilnidipine Tablet in treatment of essential high blood pressure in India
- Conditions
- Essential (primary) hypertension, Essential Hypertension,
- Registration Number
- CTRI/2019/01/016858
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
This is a multicentric, open label study to evaluate safety and efficacy of fixed dose combination ofOlmesartan Medoxomil, Chlorthalidone and Cilnidipine Tablet in the treatment ofessential hypertension in India. A cohort of 330 patients will be adequate andfeasible to provide all safety and efficacy related data for 300 evaluablepatients. Total study duration will be of 14 weeks which includes 2weeks of screening period and 12 weeks of treatment period.Study includes 05 visits. Patient who is on stable dose of dual therapy (as a FDC or individual drugs of Olmesartan 20mg/ 40 mg and Chlorthalidone 12.5 mg or Olmesartan 20 mg/ 40 mg and Cilnidipine10 mg or Cilnidipine 10 mg and Chlorthalidone 12.5 mg for at least 4 weeks before screeningwill be provided with study medication. The dose can be increased for patients whoseSeSBP greater than or equal to140 mm of Hg and/ or SeDBP greater thanor equal to 90 mm of Hg and who receive Olmesartan Medoxomil(20mg), Chlorthalidone (12.5 mg) and Cilnidipine (10 mg) tablet to Olmesartan Medoxomil (40 mg), Chlorthalidone(12.5 mg) and Cilnidipine (10 mg) tablet and the dose can be decreased fortolerability reasons based on investigator’s discretion in the subsequent visits. Safety assessments will include physical and vital signs examination, clinical laboratory estimation and evaluation of adverseevents/ serious adverse events (if any). Efficacy assessments will bedone during the study. Mean change in Seated Diastolic andSystolic Blood Pressure (SeDBP)/ (SeSBP) at week 4, 8 and 12 from baseline willbe analyzed. Responder (proportion of patients achieving SeDBP < 90 mm Hg and proportion of patients achieving SeSBP< 140 mm Hg) will be estimated and analyzed at week 4, 8 and 12.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 330
- Male or female patient aged between 18 and 65 years (both inclusive) 2.Patient having seated diastolic BP (SeDBP) 90 to 110 mm of Hg (both inclusive) and seated systolic BP (SeSBP) 140 to 200 mm of Hg (both inclusive) 3.
- Patient who is on stable dose of either of the following dual therapy (as a FDC or individual drugs) for at least 4 weeks before screening as per historical record a) Olmesartan 20 mg/ 40 mg and Chlorthalidone 12.5 mg or b) Olmesartan 20 mg/ 40 mg and Cilnidipine 10 mg or c) Cilnidipine 10 mg and Chlorthalidone 12.5 mg 4.Patient willing to give informed consent 5.Female patient of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study).
- Acceptable method of contraception includes (e.g. barrier method with spermicide).
- The "calendar method," withdrawal, or an IUD is NOT an acceptable method.
1.Pregnant or lactating woman 2.Surgical or medical condition that, in the judgment of the Investigator or Sponsor, (e.g. cholecystectomy) could interfere with absorption, distribution, metabolism, or excretion of the investigational products to be used 3.Current or past history of : a)Significant heart disease (e.g. stroke/ transient ischemic attack, heart failure, tachycardia (pulse rate > 100 beats/ min), coronary artery bypass graft surgery, coronary intervention, angina pectoris, myocardial infarction, heart block, atrial fibrillation/ flutter, hypertensive encephalopathy or valve disease) b)Other clinically significant conditions including but not limited to: pulmonary, central nervous system, thyroid, pancreatic, hepatic or renal disease (eGFR less than 60 ml/min/ 1.73m2) 4.Patient with type 2 diabetes (HbA1c greater than or equal to 7.5%) 5.Patient who is hypersensitive to study medications or any of its components 6.Current or recent substance abuse, including alcohol (as per DSM-5) 7.Participation in any experimental drug study within 60 days before screening 8.Patient who requires or takes concomitant medications (e.g. RAS inhibitors and Aliskiren) known to significantly affect BP 9.Patient judged unfit for this study by investigator (E.g. History of HIV and/ or Hepatitis B and/ or Hepatitis C) 10.Investigator, study personnel, sponsor representatives and their first degree relatives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety 12 weeks •Proportion of participants with adverse events and serious adverse events 12 weeks
- Secondary Outcome Measures
Name Time Method Mean change in Seated Diastolic Blood Pressure (SeDBP) from baseline 4, 8 and 12 weeks Mean change in Seated Systolic Blood Pressure (SeSBP) from baseline 4, 8 and 12 weeks Proportion of patients achieving SeSBP less than 140 mm of Hg (SeSBP responder) 4, 8 and 12 weeks Proportion of patients achieving SeDBP less than 90 mm of Hg (SeDBP responder) 4, 8 and 12 weeks
Trial Locations
- Locations (15)
All India Institute of Medical Sciences
🇮🇳Khordha, ORISSA, India
Aster Aadhar Hospital
🇮🇳Kolhapur, MAHARASHTRA, India
B J Medical College and Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Hedgewar Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Gandhi Hospital
🇮🇳Hyderabad, TELANGANA, India
Institute of Medical Sciences & SUM Hospital
🇮🇳Khordha, ORISSA, India
IPGME&R and SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Kanoria Hospital and Research Centre
🇮🇳Gandhinagar, GUJARAT, India
King Georges Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
Kovai Diabetes Speciality Centre & Hospital
🇮🇳Coimbatore, TAMIL NADU, India
Scroll for more (5 remaining)All India Institute of Medical Sciences🇮🇳Khordha, ORISSA, IndiaDr Anupama BeheraPrincipal investigator9437800568anupama6799@gmail.com