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Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

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ClinicalTrials.gov Identifier: NCT02087540
Recruitment Status : Unknown
Verified March 2014 by IlDong Pharmaceutical Co Ltd.
Recruitment status was:  Recruiting
First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief Summary:
To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: Telmisartan 80mg Drug: Rosuvastatin 20mg Drug: Rosuvastatin 10mg Drug: Placebo(for Telmisartan 80mg) Drug: Placebo(for Rosuvastatin 20mg) Drug: Placebo(for Rosuvastatin 10mg) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
Study Start Date : May 2013
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telmisartan 80mg & Rosuvastatin 20mg
PO, Once Daily, 8 weeks
Drug: Telmisartan 80mg
Drug: Rosuvastatin 20mg
Drug: Placebo(for Rosuvastatin 10mg)
Experimental: Telmisartan 80mg & Rosuvastatin 10mg
PO, Once Daily, 8weeks
Drug: Telmisartan 80mg
Drug: Rosuvastatin 10mg
Drug: Placebo(for Rosuvastatin 20mg)
Active Comparator: Telmisartan placebo & Rosuvastatin 20mg
PO, Once Daily, 8 weeks
Drug: Rosuvastatin 20mg
Drug: Placebo(for Telmisartan 80mg)
Drug: Placebo(for Rosuvastatin 10mg)
Active Comparator: Telmisartan Placebo & Rosuvastatin 10mg
PO, Once Daily, 8 weeks
Drug: Rosuvastatin 10mg
Drug: Placebo(for Telmisartan 80mg)
Drug: Placebo(for Rosuvastatin 20mg)
Active Comparator: Telmisartan 80mg & Rosuvastatin placebo
PO, Once Daily, 8 weeks
Drug: Telmisartan 80mg
Drug: Placebo(for Telmisartan 80mg)
Drug: Placebo(for Rosuvastatin 20mg)
Placebo Comparator: Telmisartan placebo & Rosuvastatin placebo
PO, Once Daily, 8 weeks
Drug: Placebo(for Telmisartan 80mg)
Drug: Placebo(for Rosuvastatin 20mg)
Drug: Placebo(for Rosuvastatin 10mg)



Primary Outcome Measures :
  1. •Change in seated diastolicblood pressure at 8 weeks compared to the base value [ Time Frame: at the 8 weeks ]
  2. Change in LDL-Cat 8 weeks compared to the base value (% change) [ Time Frame: at the 8 weeks ]

Secondary Outcome Measures :
  1. Change in seateddiastolic blood pressure [ Time Frame: at 2,4 8 weeks ]
  2. Change in seated systolic blood pressure [ Time Frame: at 2,4,8weeks ]
  3. Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)] [ Time Frame: at 2, 4 and 8 weeks ]
  4. Change in LDL-Cat compared to the base value (% change) [ Time Frame: 2, 4 and 8 weeks ]
  5. Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change) [ Time Frame: at 2, 4 and 8 weeks ]
  6. Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL) [ Time Frame: at 2, 4 and 8 weeks ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent
  • Men and women >18 years of age
  • Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent

Exclusion Criteria:

  • Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.
  • Other exclusions applied

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087540


Locations
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Korea, Republic of
The Catholic University of Saint Mary's Hosiptal Recruiting
Seoul, Korea, Republic of
Contact: wook-seong chung, MD       chungws@catholic.ac.kr   
Principal Investigator: wook-seong Chung, MD         
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd

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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02087540     History of Changes
Other Study ID Numbers: ID_Telotan_1203
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Telmisartan
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists