Health Condition 1: I159- Secondary hypertension, unspecified
Conditions
Interventions
Intervention1: Arm A
FDC of Metoprolol succinate 50 mg plus Amlodipine 5 mg plus Chlorthalidone 6.25 mg Tablets and Placebo
Arm B:
FDC of Metoprolol succinate 50 mg plus Amlodipine 5 mg plus Chlortha
Sponsors
Ajanta Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged between 18 and 75 years (both inclusive). 2. Subjects those who are uncontrolled on FDC of Metoprolol succinate 50 mg + Amlodipine 5 mg. 3. Subjects with the history of uncontrolled essential hypertension [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable dose of two antihypertensive medications in recommended dose for atleast 4 weeks. 4. As judged by the Investigator, based on a clinical evaluation performed during the screening period. 5. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. 6. Female subjects of childbearing potential must be willing to use acceptable method of contraception or post-menopausal for at least one year or surgically sterile.
Exclusion criteria
Exclusion criteria: Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation. Subjects with EF Subjects diagnosed with Secondary or Malignant Hypertension. Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in SeSBP between baseline and 12 weeks. The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE) Timepoint: Mean change in SeSBP between baseline and 12 weeks. The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in SeDBP from baseline [Time frame: 4, 8 and 12 weeks]. Mean change in SeSBP from baseline [Time frame: 4, 8 and 12 weeks]. Proportion of patients achieving SeSBP 140 mmHg (SeSBP responder) [Time frame: 4, 8 and 12 weeks]. Proportion of patients achieving SeDBP 90 mmHg (SeDBP responder) [Time frame: 4, 8 and 12 weeks]. Mean change in Ambulatory Blood Pressure (Mean 24 hour SBP and DBP) from as compared to baseline to the end of study (12 weeks). The assessment of tolerability of Investigational Product will be based on incidence of AEs and SAEs and changes in laboratory values. Timepoint: Baseline 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Ravindra Mote
Mediclin Clinical Research
Outcome results
None listed