A clinical trial to study the effect of two combinations, Telmisartan+ Amlodipine +Hydrochlorothiazide and Telmisartan + Hydrochlorothiazide

A Phase 3, Multi-centric, Single blind, Randomized, Comparative study to assess the efficacy and safety of fixed dose combination of Telmisartan + Amlodipine + Hydrochlorothiazide bi-layered tablet verses Telmisartan + Hydrochlorothiazide tablet for the treatment in patients with essential hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000494

Enrollment

220

Registered

2010-06-01

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

None listed

Interventions

Intervention1: Telmisartan + Amlodipine + Hydrochlorothiazide: 40 mg + 5 mg + 12.5 mg Control Intervention1: Telmisartan + Hydrochlorothiazide: 40 mg + 12.5 mg

Eligibility

Inclusion criteria

Inclusion criteria: Males or Females with essential hypertension (SBP 140-200 mmHg DBP 90-120 mmHg), age >18 yrs, wiiling to follow up and informed consent, etc

Exclusion criteria

Exclusion criteria: Pregnant, lactating women, secondary hypertension,uncontrolled diabetes, etc

Design outcomes

Primary

Measure	Time frame
Reduction in SBP/DBPTimepoint: 10 weeks	—

Secondary

Measure	Time frame
safety of combinationTimepoint: 10 weeks	—

Countries

India

Contacts

Public ContactDr Manish Maladkar

scientific@aristopharma.org02226739999

Outcome results