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

Phase 1

Conditions: obesity linked hypertension
MedDRA version: 19.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-000571-25-ES

Lead Sponsor: Fundació Clinic per a la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Seek the optimal treatment for hypertension in severe obesity patients aiming to reach hypertension targets and normalize circadian hypertension (dipper status);Secondary Objective: Seek the treatment for hypertension in severe obesity patients aiming to reach optimal hypertension levels and normalize night and day hypertension;Primary end point(s): median systolic and diastolic arterial pressure measured during 24 h;Timepoint(s) of evaluation of this end point: weeks 3 and 10

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.proportion of patients with dipper status at the end of the study.<br>2.reduction op pulse pressure<br>3.plasma noradrenaline<br>4.plasma renine and aldosterone activity<br>5.malondialdehide<br>6.CRPu and white blood cells<br>7.change in insuline, glucose, HOMA<br>8.ANP.;Timepoint(s) of evaluation of this end point: 10 weeks