Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: FDC of Azelnidipine 16mg and
Telmisartan 40mg: Once daily For 12 weeks
Control Intervention1: FDC of Amlodipine 5mg and
Telmisartan 40 mg: Once daily For 12 weeks
Sponsors
Dr Akshay Ashok Bafna
Eligibility
Inclusion criteria
Inclusion criteria: I. Patients of either sex aged between 18 to 75years (both inclusive) II. Treatment Naïve hypertensive patients with stage II hypertension or patients who are not controlled on Telmisartan monotherapy (40 mg) with Stage I or II hypertension III. Patients willing to provide written informed consent and comply with the protocol requirements IV. Subjects having no abnormalities in general physical examination
Exclusion criteria
Exclusion criteria: 1. Patients with severe hypertension (defined as a DBP ?120 mmHg or SBP ?180 mmHg) 2. Patients with suspected secondary hypertension, heart failure & diagnosed cardiovascular diseases, new cerebrovascular diseases, 3. Patients using any other concomitant medications known to affect BP or medication prohibited as per protocol. 4. Known hypersensitivity or allergy to calcium channel blockers and angiotensin receptor blockers 5. Patients with the history of Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patient postâ??renal transplant or with only one functioning kidney 6. Patients with history of any other clinically significant uncontrolled systemic diseases such as pulmonary, renal, neurological, psychiatric, gastrointestinal, metabolic, endocrine (uncontrolled diabetes mellitus), immunological or hematological disorders or malignancy 7. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 8. Those who smoke >1 pack of cigarettes per day 9. Patients with continuing history of alcohol and/or drug abuse 10. Participation in another clinical trial within 3 months prior to screening 11. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in seated office blood pressure (SBP & DBP) from baseline to end of 12 weeks in the two groupsTimepoint: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| For Efficacy; Propotion of patients achieving normal blood pressure (SBP120 and DBP80 mmHg) at end of 4 & 12 weeks. Change in pulse rate from baseline to end of 4 & 12 weeks in two groups. Change in UACR from baseline to end of 12 weeks in two group.Timepoint: From Baseline(week 0) to end of 4 week & 12 week;For Safety numbers of Adverse events & Serious adverse events reported during the study.Timepoint: From 0 to 12 weeks | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed