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

An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination tablets of Nebivolol & Indapamide (as sustained release) in comparison with Nebivolol tablets in patients suffering from hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000683

Enrollment

200

Registered

2009-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: null- Hypertension

Interventions

Intervention1: Fixed-dose combination tablets of Nebivolol 5 mg & Indapamide 1.5 mg (as sustained release): Once in a day for 6 weeks Control Intervention1: Nebivolol 5 mg tablets: Once in a day for 6

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex ï?³18 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Secondary

Measure	Time frame
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)Timepoint: 2,4 & 6 weeks	—

Primary

Measure	Time frame
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)Timepoint: 2,4 & 6 weeks	—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026