Evaluation of the efficacy and safety of a fixed dose combination of Rosuvastatin Calcium and Telmisartan with monotherapy of Rosuvastatin Calcium or Telmisartan on Mild to Moderate high blood pressure patients with high cholesterol.

A Multicentric, Comparative Controlled, Randomized, Parallel-Group, Phase III Study to Evaluate the Safety and Efficacy of FDC Containing Rosuvastatin Calcium and Telmisartan on Mild to Moderate Hypertension in Dyslipidemic Patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/01/002340

Enrollment

200

Registered

2012-01-16

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- Dyslipidemic patients with mild to moderate hypertension

Interventions

Intervention1: FDC tablet containing Rosuvastatin and Telmisartan: FDC tablet containing Rosuvastatin 5 mg + Telmisartan 20 mg

Once daily for 10 weeks Intervention2: FDC tablet containing Rosuvastatin and Telmisartan: FDC tablet containing Rosuvastatin 5 mg + Telmisartan 40 mg

Once daily for 10 weeks Intervention3: FDC tablet containing Rosuvastatin and Telmisartan: FDC tablet containing Rosuvastatin 10 mg + Telmisartan 20 mg

Once daily for 10 weeks Intervention4: FDC tablet containing Rosuvastatin and Telmisartan: FDC tablet containing Rosuvastatin 10 mg + Telmisartan 40 mg

Once daily for 10 weeks Intervention5: FDC tablet containing Rosuvastatin and Telmisartan: FDC tablet containing Rosuvastatin 20 mg + Telmisartan 20 mg

Once daily for 10 weeks Intervention6: FDC tablet containing Rosuvastatin and Telmisartan: FDC tablet containing Rosuvastatin 20 mg + Telmisartan 40 mg

Once daily for 10 weeks Control Intervention1: Rosuvastatin: Tablet containing Rosuvastatin 10 mg

Once daily for 10 weeks. Control Intervention2: Telmisartan: Tablet containing Telmisartan 40 mg

Once daily for 10 weeks

Eligibility

Inclusion criteria

Inclusion criteria: ï?? Male and female patients in the age group of 20-80 years ï?? Females of childbearing potential should have a negative pregnancy test at the prestudy visit and agree to use contraception during the study. ï?? Patients willing to give informed consent. ï?? Mild to moderate primary type hypertensive patient. ï?? Any patient with hypercholesterolemia (with Non-HDL-C) who has above target goal according to NCEP-ATP III after 3 months of treatment with conventional statin doses, e.g. simvastatin 10-40 mg, atorvastatin 10-40 mg or rosuvastatin 5-20 mg. ï?? Patients who are willing to comply with all study requirements

Exclusion criteria

Exclusion criteria: ï?? Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits). ï?? Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment. ï?? Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study. ï?? Women of childbearing potential who are not using effective and medically acceptable methods of contraception. ï?? Patients who are meeting any of the contraindications of the study medication according to the approved SPC. ï?? Secondary type of hypertensive patients. ï?? Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism [thyroid stimulating hormone (TSH) > 5 IU/mL], liver disease (ALT and/or AST levels > 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption > 3 drinks/day for men and > 2 drinks/day for women, and current or previous gout. ï?? Patients with diabetes will be included in the study if they are adequately controlled (HbA1c ï?? Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period). ï?? Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded.

Design outcomes

Primary

Measure	Time frame
To evaluate decrease in the blood pressure of hypertensive patients with LDL-C lowering efficacy of telmisartan 40 mg, or rosuvastatin 10 mg monotherapy with fixed dose combinations of telmisartan (40/20 mg) and rosuvastatin (20/10/5 mg).Timepoint: 10 weeks	—

Secondary

Measure	Time frame
To assess and compare the effects of telmisartan (40/20 mg) in combination with rosuvastatin (20/10/5 mg) vs. monotherapy of rosuvastatin 10 mg and telmisertan 40 mg on percentage change of LDL-C, HDL-C, total cholesterol (TC), TG, non-HDL-C, TC/HDL-C, LDL-C/HDL-C, nonHDL-C/HDL-C and high sensitivity C-reactive protein (hs-CRP) from baseline after 10 weeks combination therapy.Timepoint: 10 weeks	—

Countries

India

Contacts

Public ContactDr Vanita Sabhahit

Jadavpur University

tkpal12@gmail.com03324146967

Outcome results

None listed

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