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OpenTrials
Completed

NCT Number: NCT03088254

Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin

To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.

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Key information

Conditions

Dyslipidemia With Hypertension

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chungnam National University Hospital, Daejeon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dyslipidemia with hypertesion
  • msSBP < 180 mmHg
  • msDBP < 110 mmHg
  • LDL-C ≤ 250 mg/dL
  • Triglycerides < 400 mg/dL

Exclusion criteria

  • At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
  • CK normal range ≥ 2 times
  • Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
  • AST or ALT ≥ 2 times
  • Uncontrolled diabetes mellitus (HbA1c≥9%)
  • CLcr < 30 mL/min/1.73m^2
  • K > 5.5 mEq/L
  • Other exclusion applied

Treatment and study plan

Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)

Drug

Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks

Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)

Drug

Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks

Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)

Drug

Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks

Primary outcomes

  1. change of LDL-C

    Time frame: baseline and 8 weeks

  2. change of msSBP

    Time frame: baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2017
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.