Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide

NCT02710071 | Completed Phase 4 Results

• 1 other identifier: 110342
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep. They often develop high blood pressure. We are not sure what drug is best to treat the high blood pressure. This study will give the patients nebivolol or hydrochlorothiazide (HCTZ) for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24 hour monitoring.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure

  24-h Systolic Blood Pressure is the average of all 24-h Ambulatory Systolic Blood Pressure recordings. The Wake Period Systolic Blood Pressure is the average of all Systolic Blood Pressures recorded every 15 minutes during the wake period. The Sleep Period Systolic Blood pressure is the average of all Systolic Blood Pressures recorded every 30 minutes during the sleep period. 24-h Diastolic Blood Pressure is the average of all 24-h Ambulatory Diastolic Blood Pressure recordings. The Wake Period Diastolic Blood Pressure is the average of all Diastolic Blood Pressures recorded every 15 minutes during the wake period. The Sleep Period Diastolic Blood pressure is the average of all Diastolic Blood Pressures recorded every 30 minutes during the sleep period.

  At the end of 2 weeks of placebo therapy, at the end of 6 weeks of Nebivolol therapy and at the end of 6 weeks of hydrochlorothiazide therapy.

Study Arms (2)

Placebo, Nebivolol, Hydrochlorothyazide

EXPERIMENTAL

Sequence: Placebo, Then Nebivolol 5mg for 2 weeks followed by nebivolol 10 mg for 4 weeks,Then Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks.

Drug: Nebivolol; Drug: Hydrochlorothiazide

Placebo, Hydrochlorothyazide, Nebivolol

EXPERIMENTAL

Sequence: Placebo, Then Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks, Then Nebivolol 5mg for 2 weeks followed by nebivolol 10 mg for 4 weeks.

Drug: Nebivolol; Drug: Hydrochlorothiazide

Interventions

Nebivolol DRUG

Nebivolol 5mg then nebivolol 10 mg

Also known as: Bystolic

Placebo, Hydrochlorothyazide, Nebivolol; Placebo, Nebivolol, Hydrochlorothyazide

Hydrochlorothiazide DRUG

Hydrochlorothiazide 12.5 mg then hydrochlorothiazide 25 mg

Also known as: Hydrodiuril

Placebo, Hydrochlorothyazide, Nebivolol; Placebo, Nebivolol, Hydrochlorothyazide

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ranging from 20 - 80 years
• Body mass index (BMI) of 20-38 to include the typical obese OSA patients
• Hypertension with blood pressures \> 140/90 but less than 180/105 mmHg.
• Apnea-hypopnea index above 10

You may not qualify if:

• Receiving sleep medicines (including heavy alcohol use) or drugs with adverse interactions with study medication.
• Women who have premenstrual syndrome, or those who are pregnant or capable of pregnancy and unwilling to use effective non-hormonal contraception
• Shift workers or have symptoms of narcolepsy, restless legs syndrome or insomnia, in order to minimize confounding effects of other sleep disorders
• Have apneas which are primarily central
• Have sleep fragmentation caused by syndromes such as chronic pain or movement disorders
• Have diseases such as asthma or chronic obstructive pulmonary disease that compromises respiration.
• Have known coronary or cerebral vascular disease, history of arrhythmias, cardiomyopathy, history of psychosis, current alcohol or drug abuse.
• Have any contraindications to any study materials, such as heart block.
• Have secondary hypertension
• Have creatinine levels above 2.5 mg %, more than 1+ proteinuria by dipstick, hematuria or electrolyte disorders.

Sponsors & Collaborators

• University of California, San Diego: lead

Related Publications (1)

• Ziegler MG, Milic M, Sun P. Antihypertensive therapy for patients with obstructive sleep apnea. Curr Opin Nephrol Hypertens. 2011 Jan;20(1):50-5. doi: 10.1097/MNH.0b013e3283402eb5.

  PMID: 21326007 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Results Point of Contact

• Title: Michael G. Ziegler, M.D.
• Organization: University of California San Diego

mziegler@ucsd.edu

619 543 2885

Study Officials

• Michael G. Ziegler, M.D.

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 16, 2016
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share