Comparison of Olmesartan +Amlodipine +Hydrochlorothiazide combination with Olmesartan +Hydrochlorothiazide combination in essential hypertension.

A phase III, randomized, single blind, multicenter, comparative, prospective clinical trial to assess the efficacy and safety of FDC of Olmesartan +Amlodipine +Hydrochlorothiazide bi-layered tablet verses FDC of Olmesartan +Hydrochlorothiazide tablet in patients for the management of essential hypertension.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/006071

Enrollment

220

Registered

2011-01-19

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: FDC of Olmesartan + Amlodipine + Hydrochlorothiazide: FDC of Olmesartan(20mg) + Amlodipine(5mg) + Hydrochlorothiazide(12.5mg) per day Control Intervention1: FDC of Olmesartan + Hydrochl

Eligibility

Inclusion criteria

Inclusion criteria: patients >18 yrs with mild to moderate uncomplicated essential hypertension, patients with mean sitting systolic BP 140-200 mmHg and mean sitting diastolic BP 90-120 mmHg. patients with written informed consent and should be on single antihypertensive drug, etc.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women, patients with mean sitting systolic BP >200 mmHg and mean sitting diastolic BP >120 mmHg. suspected secondary hypertension, history of MI, stroke, TIA, other Cv events in last 6 months, patients with uncorrected volume or sodium depletion, etc.

Design outcomes

Primary

Measure	Time frame
Reduction in arterial blood pressureTimepoint: Twelve weeks therapy	—

Secondary

Measure	Time frame
Safety of FDCTimepoint: Twelve week therapy	—

Countries

India

Contacts

Public ContactDr. Manish Maladkar

Head Medical affairs

scientific@aristopharma.org02226739999

Outcome results