Impact of Losartan in hypertensive men with obstructive sleep apnea - LOSARTANPAP

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000869-38-SE

Enrollment

Registered

2008-03-19

Start date

2008-06-02

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Hypertension and obstructive sleep apnea (OSA)

Interventions

Trade Name: Cozaar Product Name: Losartan Product Code: 06/04603 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Losartan CAS Number: 06/04603

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Men -Age 50-69 years -Body-Mass-Index =140 mmHg and/or Diastolic Blood Pressure >=95 mmHg -No known clinical disease except hypertension -No cardiovascular medication -Apnea-Hypopnea-Index (AHI) =15/h (obstructive sleep apnea) by sleep-recording -Written informed consent from the participant 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: AHI 5-14.9/h by sleep-recording Manifest diabetes, liver- or kidney disease according to blood samples at screening Signs of atrial fibrillation or former myocardial infarction at electrocardiogram

Design outcomes

Primary

Measure	Time frame
Main Objective: To address if blood pressure response to Losartan is less adequate in hypertensive men with obstructive sleep apnea (OSA) compared to those without this state. ;Secondary Objective: To address if these groups differ from eachother in response to Losartan regarding the neuroendocrine hormones and cardiovascular biomarkers. We will also address if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) has an additive effect regarding blood pressure response to Losartan in this group. ;Primary end point(s): Blood-pressure response (ambulatory 24-h blood pressure) after 6 weeks of Losartan (50 mg) daily compared to baseline in patients with and without obstructive sleep apnea. Blood-pressure response (ambulatory 24-h blood pressure) after another 6 week-period in subgroup of hypertensive patients with obstructive sleep apnea with "Losartan only" compared to the treatment with "Losartan and CPAP"	—

Measure

Time frame

Main Objective: To address if blood pressure response to Losartan is less adequate in hypertensive men with obstructive sleep apnea (OSA) compared to those without this state. ;Secondary Objective: To address if these groups differ from eachother in response to Losartan regarding the neuroendocrine hormones and cardiovascular biomarkers. We will also address if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) has an additive effect regarding blood pressure response to Losartan in this group. ;Primary end point(s): Blood-pressure response (ambulatory 24-h blood pressure) after 6 weeks of Losartan (50 mg) daily compared to baseline in patients with and without obstructive sleep apnea. Blood-pressure response (ambulatory 24-h blood pressure) after another 6 week-period in subgroup of hypertensive patients with obstructive sleep apnea with "Losartan only" compared to the treatment with "Losartan and CPAP"

—

Countries

Sweden

Outcome results

None listed

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