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A clinical trial to study the effects of two drugs Olmesartan and metoprolol in patients with high blood pressure and heart disease

To evaluate the safety and efficacy of fixed dose combination of Olmesartan and Metoprolol succinate ER in hypertensive patients with Cardiovascular Disease (CVD).

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2010/091/001438
Enrollment
1000
Registered
2010-11-15
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: null- Hypertension with Cardiovascular Disease

Interventions

Intervention1: Olmax-M [Olmesartan (20mg) and Metoprolol succinate ER (25mg)] Tablet and Olmesartan (20mg) and Metoprolol succinate ER (50mg) Tablet: Olmax-M [Olmesartan (20mg) and Metoprolol succinat

Sponsors

Glenmark Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ? All CVD patients (prior MI, ACS, PCI, CABG) with hypertension OR ? All CVD patients (prior MI, ACS, PCI, CABG) with Uncontrolled hypertension (BP > 140/90 mmHg for hypertensive patients and BP > 130/80 mmHg for hypertensive patients with Diabetes or renal disease).

Exclusion criteria

Exclusion criteria: ? Not willing to provide written informed consent and comply with the protocol ? Age below 18 years and above 65 years ? Secondary hypertension ? Patients requiring concomitant anti-hypertensive medications other than angiotensin receptor blockers (ARBs) or Metoprolol ? Uncontrolled diabetes mellitus ? Baseline laboratory values outside the clinically acceptable limits ? Pregnant women and lactating mothers ? Females of child bearing age not practicing contraception or not willing to use barrier contraceptive ? Known hypersensitivity to Olmesartan/Metoprolol ? Patients with effort angina more than class II (Drugs like Nitrates, ranolazine or Trimetazidine can be used but not amlodipine or nicorandil). ? Sick sinus syndrome or Atrioventricular block or Heart Failure

Design outcomes

Primary

MeasureTime frame
Magnitude of systolic and diastolic blood pressure reduction from baseline at end of 8 weeks of treatment Percent of subjects reaching blood pressure target of 140/90 mmHg in hypertensive patients and 130/80mmHg in hypertensive patients with diabetes and renal disease at end of 8 weeks of treatment Timepoint: End of 8 weeks of treatment

Countries

India

Contacts

Public ContactProf Dr JC Mohan

President of the Indian Society of Interventional Cardiology

jcmohan@vsnl.com9811061392

Outcome results

None listed

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