A Clinical Study to observe the effects of combination of Telmisartan and Amelodipine in patients with Uncontrolled Hypertension alone,Or with Type II Diabetes Mellitus

To evaluate the safety and efficacy of fixed dose combination of Telmisartan and Amlodipine in hypertensive patients at risk of cardiovascular events. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2011/12/002189

Enrollment

1000

Registered

2011-12-02

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- Hypertensive patients at risk of cardiovascular events

Interventions

Intervention1: Telma AM and Telma 80AM: Telma AM containing Telmisartan 40 mg + Amlodipine 5 mg (once daily) and Telma 80AM containing Telmisartan 80 mg + Amlodipine 5 mg (once daily) Control Inte

Eligibility

Inclusion criteria

Inclusion criteria: Uncontrolled hypertensives (BP more than 140/90 despite monotherapy with Telmisartan and Amlodipine OR BP more than 130/80 mmHg for hypertensive patients with Diabetes

Exclusion criteria

Exclusion criteria: Age below 18 years and above 75years Secondary hypertension Patients requiring concomitant anti-hypertensive medications other than angiotensin receptor blockers (ARBs) or Amlodipine Uncontrolled diabetes mellitus Pregnant women and lactating mothers Females of child bearing age not practicing contraception or not willing to use barrier contraceptive Known hypersensitivity to Telmisartan/Amlodipine Patients with severe and or significant renal, hepatic or cardiac disease Not willing to provide written informed consent and comply with the protocol

Design outcomes

Primary

Measure	Time 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 with uncontrolled hypertension and 130/80mmHg in hypertensive patients with diabetes at end of 8 weeks of treatment Timepoint: 8 weeks	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Swati Lad

swatil@glenmarkpharma.com9820191802

Outcome results

None listed

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