CTRI/2020/03/023708CompletedPhase 3
A Phase III Randomized, Double blind, Parallel Group Comparative Clinical Trial to Evaluate the safety, tolerability and efficacy of 2 Fixed dose combinations of Azelnidipine and Chlorthalidone when compared with fixed dose combination of Amlodipine and Hydrochlorothiazide in patients with Stage II hypertension.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Synokem Pharmaceuticals Ltd
- Enrollment
- 210
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects aged between 18 and 65 years (both inclusive).
- •2.Treatment naïve subjects diagnosed with stage 2 hypertension having mean seated SBP of >=160 to <=180 mmHg and mean seated DBP >=100 to <=110 mmHg (3 readings will be taken by validated automated blood pressure machine in sitting position, first reading will be taken after 15 min. rest and subsequent two readings will be recorded at the interval of 2 min. each).
- •3. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •4.Subjects willing to comply with the protocol requirements.
Exclusion Criteria
- •1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •2.Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
- •3. Subjects with known case of Secondary or Malignant Hypertension.
- •4.Subjects with evidence of postural hypotension (defined as drop in >20 mmHg for systolic blood pressure and >10 mmHg for diastolic blood pressure after assuming the standing posture from supine or sitting position).
- •5. Subjects with known case of symptomatic congestive heart failure, unstable angina pectoris, sinus node dysfunction and any clinically significant cardiac arrhythmias.
- •6. Subject who has had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in last 1 year.
- •7.Subjects with known case of Stroke.
- •8.Subjects with abnormal eGFR ( <60 mL/min/1.73 m2).
- •9.Subjects with known case of bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one functioning kidney. 1
- •10. Subjects with hyponatremia as per blood biochemistry results at screening.
- •11. Subjects with hyperkalemia and hypokalemia as per blood biochemistry results at screening.
- •12. Subjects with abnormal Liver Function Tests (Total bilirubin, SGOT & SGPT) with values more than 2.5 times the upper limit of normal.
- •13.Subjects with abnormal Thyroid Function Test (TSH).
- •14.Subjects with Type 1 diabetes & Type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
- •15.Subjects with medical history of Oncological Conditions since last 5 years.
- •16.Subjects with known case of Epileptic seizures.
- •17.Subjects with clinical history of bipolar disorder.
- •18.Subjects with known case of HIV, Hepatitis B & C.
- •19.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •20. Females who are not ready to use acceptable contraceptive methods during the course of study.
- •21.Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •22.Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •23.Suspected inability or unwillingness to comply with the study procedures.
Investigators
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