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Comparison of the Efficacy and Safety of Low Dose Combination Therapy and High Dose Monotherapy for the treatment of Hypertension.

â??Comparison of the Efficacy and Safety of High Dose Monotherapy and Low Dose Combination of Telmisartan and/or Amlodipine in Inadequately Controlled Hypertensive Patients taking Low Dose Monotherapy of Either Drug- A Single Center, Open Label, Three-Arm, Randomized, Parallel Group, Prospective Study.â??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/08/003905
Enrollment
90
Registered
2013-08-20
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

Interventions

Intervention1: Telmisartan and Amlodipine Combination: Telmisartan 40 mg and Amlodipine 5 mg combination, once daily, orally for 8 Weeks. Both are anti-hypertensive drugs marketed in India Control Int

Sponsors

Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Hypertensive patients with uncontrolled blood pressure (Systolic BP >= 140 to 179 mmHg and/or Diastolic BP >= 90 to 109 mmHg) on low dose monotherapy with either Amlodipine ( 2 Age 18 to 60 years, either gender. 3 Patients who are willing to participate and sign consent document. 4 Patient willing to comply with the protocol requirements.

Exclusion criteria

Exclusion criteria: 1 Secondary Hypertension. 2 Clinically evident concomitant disorder such as cardiovascular, renal, hepatic, endocrine, neurological, psychiatric or other complicating diseases or severe co-morbidities. 3 Pregnant or lactating women. 4 Female patients of childbearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study period. 5 Patients with known hypersensitivity to any of the test drug. 6 Patients with alcohol or drug dependence. 7 Patients with stage 3 hypertension (Systolic BP >= 180 mmHg and/or Diastolic BP >= 110 mmHg) 8 Patients who had any major surgery within 4 weeks of screening. 9 Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.

Design outcomes

Primary

MeasureTime frame
Improvement in Blood Pressure Control from BaselineTimepoint: 56 Days of Study Duration

Secondary

MeasureTime frame
Improvement in symptoms associated with high blood pressureTimepoint: 56 Days of Study Duration

Countries

India

Contacts

Public ContactJaswant Goyal

Mahatma Gandhi Medical College and Hospital

dr.z.y.khan@gmail.com9314096969

Outcome results

None listed

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