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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000571-25-ES

Enrollment

Unknown

Registered

2016-04-20

Start date

2016-06-16

Completion date

Unknown

Last updated

2016-06-20

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

Conditions

obesity linked hypertension MedDRA version: 19.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: IXIA PLUS Pharmaceutical Form: Tablet INN or Proposed INN: olmesartan CAS Number: 144689-63-4 Other descriptive name: OLMESARTAN MEDOXOMIL Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion 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 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Spain

Contacts

Public ContactUnidad de Obesidad

Hospital Clinic Barcelona

349322754004309

Outcome results

None listed

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