Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: null- Essential Hypertension
Conditions
Interventions
Intervention1: FDC of Olmesartan Medoxomil (20 mg), Chlorthalidone (12.5 mg) and Cilnidipine (10 mg) tablet
Manufacturer: Sun Pharma Laboratories Limited (SPLL): One tablet to be taken once a day aft
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety â?¢Proportion of participants with adverse events and serious adverse eventsTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Seated Diastolic Blood Pressure (SeDBP) from baselineTimepoint: 4, 8 and 12 weeks;Mean change in Seated Systolic Blood Pressure (SeSBP) from baselineTimepoint: 4, 8 and 12 weeks;Proportion of patients achieving SeSBP less than 140 mm of Hg (SeSBP responder)Timepoint: 4, 8 and 12 weeks;Proportion of patients achieving SeDBP less than 90 mm of Hg (SeDBP responder)Timepoint: 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Sun Pharma Laboratories Limited (SPLL)
Outcome results
None listed