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Clinical Trials/EUCTR2016-000571-25-ES
EUCTR2016-000571-25-ES
Active, not recruiting
Phase 1

Seeking the ideal anti-hypertensive therapy in obesity-related hypertension. An open-label, single center, randomized clinical trial.

Fundació Clinic per a la Recerca Biomèdica0 sitesApril 20, 2016
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Conditionsobesity linked hypertensionMedDRA version: 19.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsIXIA PLUSBALZAKBALZAK PLUS

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
obesity linked hypertension
Sponsor
Fundació Clinic per a la Recerca Biomèdica
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 20, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundació Clinic per a la Recerca Biomèdica

Eligibility Criteria

Inclusion Criteria

  • •A. Age between 18 and 65\.
  • •B. grade II\-III obesity
  • •C. Moderate hypertension, with no end\-organ affectation
  • •D. Current treatment with less than 3 drugs.
  • •E.normal renal function with GF (MDRD) \> 60 ml/min.
  • •F. Candidates to bariatric surgery.
  • •G. written informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •A.Pregnant or lactating women
  • •B.Fertile women not using a high effective contracepive method (in accordance with Clinical Trial Facilitation Group guidelines)
  • •C. secondary hypertension
  • •D. End\-organ hypertension not allowing treatment discontinuation
  • •E. Prior bariatric surgery
  • •F. Any contraindication or intolerance to olmesartan, amlodipine or thiazides.

Outcomes

Primary Outcomes

Not specified

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