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Pharmacokinetic interaction between rosuvastatin and telmisartan

Pharmacokinetic interaction between rosuvastatin and telmisartan

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-13003006
Enrollment
Unknown
Registered
2013-01-19
Start date
2013-03-18
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidaemia, hypertension

Interventions

one group::Rosuvastatin 10mg for two days and Telmisartan 40mg for 14 days

Sponsors

Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Body mass index: 18-30 kg/m2; treatment with rosuvastatin 10 mg daily with or without other lipid-modifying drugs for at least for 4 weeks according to the current HA guidelines; borderline high or high blood pressure (systolic blood pressure >=120 mmHg or diastolic blood pressure >=80 mmHg) with or without anti-hypertensive treatment other than angiotensin-converting enzyme inhibitors (ACEIs) or ARBs.

Exclusion criteria

Exclusion criteria: History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study; clinically significant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test or upon Investigator decision; adjustment of lipid-lowering treatment within 6 weeks prior to the study in patients with hyperlipidaemia; treatment of telmisartan or other ARBs or ACEIs within 4 weeks prior to the study; adjustment of concomitant medications within 4 weeks prior to the study; taking other drugs known to interact with rosuvastatin or telmisartan; volunteer in any clinical drug study within 2 months prior to this study; history of allergy or hypersensitivity to rosuvastatin or telmisartan; type 2 diabetes with poor glyceamic control (HbA1c> 8.5%); impaired hepatic or renal disease function (alanine aminotransferase [ALT] >1.5 times upper limit of normal range; serum creatinine > 140 mol/L); regular heavy alcohol consumption (>21 units of alcohol per week).

Design outcomes

Primary

MeasureTime frame
Differences in statin pharmacokinetic parameters with and without telmisartan;

Secondary

MeasureTime frame
Difference in pharmacokinetic parameters and interactions among genotype groups;

Contacts

Public ContactBrian Tomlinson
btomlinson@cuhk.edu.hk+852 2632-3139

Outcome results

None listed

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