Bedtime Administration of Amlodipine Versus Lisinopril (BAVLART)

Allina Health System

Status: Unknown

Conditions: Hypertension

Treatments: Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01835418

9529148100

Details and patient eligibility

About

This study seeks to compare the differences in effectiveness among individual patients treated at for hypertension with bedtime administration of amlodipine versus lisinopril. There will be an analysis of whether one medication was more effective than another and whether specific patient factors could predict who responded better to which one.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40 to 80
• Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria.
• Minimum Asleep SBP mean of ≥ 120mmHg for inclusion.

Exclusion criteria

• Current antihypertensive medication use
• Baseline GFR < 45
• Preexisting macroproteinuria
• Chronic congestive heart failure
• History of CVA
• Diabetes Mellitus
• Pregnancy
• Night-shift work
• Other preexisting contraindication to amlodipine or lisinopril

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Lisinopril

Experimental group

Description:

bedtime administration of lisinopril 20mg

Treatment:

Drug: Amlodipine

Amlodipine

Experimental group

Description:

Bedtime administration of amlodipine 5mg

Treatment:

Drug: Amlodipine