A clinical trial to study the effects of two drugs, fixed dose combination tablets of Nebivolol & Indapamide (as sustained release) and Nebivolol tablets in patients with hypertension
- Conditions
- Essential (primary) hypertension, Hypertension,
- Registration Number
- CTRI/2009/091/000683
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination tablets of Nebivolol & Indapamide (as sustained release) and Nebivolol tablets given once a day for 6 weeks in 200 patients with hypertension that will be conducted in India. The primary outcome measures will be the degree of reduction in supine diastolic blood pressure at the end of the study as compared to the baseline.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- 1.Patients of either sex 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
- 2.Patients with hypertension (defined as supine systolic and/or diastolic blood pressure more than 140 mm Hg and 90 mm Hg respectively) 3.Informed consent of the patient/relative.
1.Pregnancy and/or Lactation 2.Patients with anuria, progressive & severe oliguria, hepatic coma, hyponatremia, hypokalaemia, hyperuricemia, secondary hypertension, systemic lupus erythematosus 3.Patients with bronchial asthma, diabetes, thyrotoxicosis, peripheral vascular disease, severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure or sick sinus syndrome 4.Patients with hepatic and /or renal dysfunction 5.Patients with a history of known hypersensitivity to either Nebivolol or Indapamide or to other sulfonamide derivatives or to any other component of the study drugs 6.Patients with any other serious concurrent illness or malignancy 7.Patients with continuing history of alcohol and / or drug abuse 8.Participation in another clinical trial in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degree of reduction in supine diastolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0) 2,4 & 6 weeks
- Secondary Outcome Measures
Name Time Method The degree of reduction in supine systolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0) 2,4 & 6 weeks
Trial Locations
- Locations (5)
Govt. Medical College & Sir T. Hospital, Bhavnagar
🇮🇳Bhavnagar, GUJARAT, India
Govt. Medical College, Surat
🇮🇳Surat, GUJARAT, India
Medilink Hospital, Ahmedabad
🇮🇳Ahmadabad, GUJARAT, India
S.P. Medical College and A.G. Hospitals, Bikaner
🇮🇳Bikaner, RAJASTHAN, India
Smt. Bhikhiben Kanjibhai Shah Medical Institute & Research Centre, Vadodara
🇮🇳Research, India
Govt. Medical College & Sir T. Hospital, Bhavnagar🇮🇳Bhavnagar, GUJARAT, IndiaDr. Panna KamdarPrincipal investigatordrpam2007@hotmail.com