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Trial record 26 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Lorsatana + Hydrochlorothiazide Produced By Lab Hypermarcas S/A. In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01692717
Recruitment Status : Unknown
Verified September 2012 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : September 25, 2012
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):
Azidus Brasil

Brief Summary:
The objective of this clinical study, randomized, crossover is to evaluate the pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide) Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp & Dohme) by comparing the serum concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Atorvastatin Drug: Hydrochlorothiazide + Losartan Drug: Hydrochlorothiazide + Losartan + Atorvastatin Phase 1

Detailed Description:

The pharmacokinetic profile of the drug will also be assessed by comparing the serum concentration of active metabolites following:

  • O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT
  • carboxylic acid (E-3174, LS-CA): active metabolite of LS

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atorvastatin
Citalor (Atorvastatin) - Pfizer
Drug: Atorvastatin
10 mg
Other Name: Citalor

Drug: Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Other Name: Hyzaar

Drug: Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Other Name: Polipílula

Active Comparator: Hydrochlorothiazide + Losartan
Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme
Drug: Atorvastatin
10 mg
Other Name: Citalor

Drug: Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Other Name: Hyzaar

Drug: Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Other Name: Polipílula

Experimental: Atorvastatin + Hydrochlorothiazide + Losartan
Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
Drug: Atorvastatin
10 mg
Other Name: Citalor

Drug: Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Other Name: Hyzaar

Drug: Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Other Name: Polipílula




Primary Outcome Measures :
  1. The primary pharmacokinetic parameters for the exercise of comparability will be unchanged dosages of analytes (AT, LS and HCTZ), assessed by AUC, Tmax, Cmax and T1 / 2. [ Time Frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00. ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters are side dosages of active metabolites O-HAT and E-3174, measured by AUC, Tmax, Cmax and T1 / 2. [ Time Frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00. ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Confirm voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
  2. Age between 18 and 55 years, regardless of sex, clinically healthy and present laboratory parameters within normal limits;
  3. BMI ≥ 18.5 and ≤ 30.

Exclusion Criteria:

  1. Participation in clinical trials in the 12 months preceding the survey;
  2. History of hypersensitivity reactions to atorvastatin, losartan hydrochlorothiazide and / or any other ingredients of medicines;
  3. Alterations in clinical and laboratory criteria that interfere Principal Investigator on the study results;
  4. Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
  5. Acute illness during the 07 days preceding the start of the study;
  6. Chronic disease that determine drug delivery, such as hypertension, diabetes or any other that requires continuous use of any medicine, including use of vitamins, mineral supplements and OTCs (over-the-counter);
  7. Having made regular use of medication in the last 02 weeks before the onset of the study. The use of any medication that does not interfere with the physician's judgment on the pharmacokinetics of the drug under study, will not be considered as an exclusion criterion.
  8. Use of medications that interact with any medications association;
  9. History of or current use for at least 12 months of tobacco;
  10. Current or previous history (under 12 months) of illicit drug use;
  11. At the discretion of the Principal Investigator of the study.

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): NCT01692717


Contacts
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Contact: Alexandre Frederico, physician 55 19 38716399 alexandre@lalclinica.com.br

Locations
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Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, São Paulo, Brazil
Contact: Alexandre Frederico, physician    55 19 38716399    alexandre@lalclinica.com.br   
Sponsors and Collaborators
Azidus Brasil

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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01692717     History of Changes
Other Study ID Numbers: ALHHYP0512OR-I
Versão 01 28.05.2012 ( Other Identifier: LAL Clínica )
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Losartan
Hydrochlorothiazide
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators