# US 2013/0158080 A1 · Methods for treating hypertension in black patients

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- Number: US 2013/0158080 A1
- Document ID: US20130158080A1
- Status: Published application
- Kind: A1
- Application number: 13/709,853
- Filed: 2012-12-10
- Published: 2013-06-20
- Earliest claimed: 2011-12-15
- Assignees: Takeda Pharmaceuticals U.S.A., Inc.
- Inventors: Stuart Kupfer
- Web page: https://patentgrep.com/patent/US20130158080A1

## CPC

- A61K 31/4245: Oxadiazoles
- A61K 31/4035: Isoindoles, e.g. phthalimide
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 9/12: Antihypertensives
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to methods of treating hypertension in a black patient using a therapeutically effective amount of a combination of an angiotensin II receptor blocker and chlorthalidone.

## Claims

### Claim 1

A method of lowering blood pressure in a black patient in need of treatment thereof, the method comprising the steps of:
preferentially selecting a therapeutically effective amount of at least one angiotensin II receptor blocker (ARB) from a class of ARBs to lower the blood pressure in a black patient, wherein the ARB selected is azilsartan medoxomil; and
administering a combination of a therapeutically effective amount of the azilsartan medoxomil and a therapeutically effective amount of chlorthalidone to lower the blood pressure of the black patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the patient is administered 20 mg once per day of azilsartan medoxomil.

### Claim 3 (depends on 1)

The method of claim 1, wherein the patient is administered 40 mg once per day of azilsartan medoxomil.

### Claim 4 (depends on 1)

The method of claim 1, wherein the patient is administered 80 mg once per day of azilsartan medoxomil.

### Claim 5 (depends on 1)

The method of claim 1, wherein the chlorthalidone is administered simultaneously or sequentially with the azilsartan medoxomil.

### Claim 6 (depends on 1)

The method of claim 1, wherein the chlorthalidone and azilsartan medoxomil are administered as separate dosage forms.

### Claim 7 (depends on 1)

The method of claim 1, wherein the chlorthalidone and azilsartan medoxomil are administered in a single dosage form.

### Claim 8 (depends on 1)

The method of claim 1, wherein the patient is administered 12.5 mg once per day of chlorthalidone.

### Claim 9 (depends on 1)

The method of claim 1, wherein the patient is administered 25 mg once per day of chlorthalidone.

### Claim 10 (depends on 1)

The method of claim 1, wherein the patient is administered 20 mg of azilsartan medoxomil and 25.0 mg of chlorthalidone once per day.

### Claim 11 (depends on 1)

The method of claim 1, wherein the patient is administered 40 mg of azilsartan medoxomil and 25.0 mg of chlorthalidone once per day.

### Claim 12 (depends on 1)

The method of claim 1, wherein the patient is administered 80 mg of azilsartan medoxomil and 25.0 mg of chlorthalidone once per day.

### Claim 13 (depends on 1)

The method of claim 1, wherein the blood pressure is systolic or diastolic blood pressure.

### Claim 14 (depends on 1)

The method of claim 1, wherein the patient suffers from hypertension, heart failure, stroke, chronic kidney disease, arrhythmia, peripheral artery disease, coronary artery disease or combinations thereof.

### Claim 15 (depends on 1)

The method of claim 1, wherein the hypertension is stage 1 primary hypertension.

### Claim 16 (depends on 1)

The method of claim 1, wherein the hypertension is stage 2 primary hypertension.

### Claim 17

A method of lowering blood pressure in a black patient in need of treatment thereof, the method comprising the steps of:
preferentially administering a combination of a therapeutically effective amount of at least one angiotensin II receptor blocker (ARB) from a class of ARBs and a therapeutically effective amount of chlorthalidone to lower the blood pressure in a black patient, wherein the ARB administered to the black patient is azilsartan medoxomil.

### Claim 18 (depends on 17)

The method of claim 17, wherein the patient is administered 20 mg once per day of azilsartan medoxomil.

### Claim 19 (depends on 17)

The method of claim 17, wherein the patient is administered 40 mg once per day of azilsartan medoxomil.

### Claim 20 (depends on 17)

The method of claim 17, wherein the patient is administered 80 mg once per day of azilsartan medoxomil.

### Claim 21 (depends on 17)

The method of claim 17, wherein the chlorthalidone is administered simultaneously or sequentially with the azilsartan medoxomil.

### Claim 22 (depends on 17)

The method of claim 17, wherein the chlorthalidone and azilsartan medoxomil are administered as separate dosage forms.

### Claim 23 (depends on 17)

The method of claim 17, wherein the chlorthalidone and azilsartan medoxomil are administered in a single dosage form.

### Claim 24 (depends on 17)

The method of claim 17, wherein the patient is administered 12.5 mg once per day of chlorthalidone.

### Claim 25 (depends on 17)

The method of claim 17, wherein the patient is administered 25 mg once per day of chlorthalidone.

### Claim 26 (depends on 17)

The method of claim 17, wherein the patient is administered 20 mg of azilsartan medoxomil and 25.0 mg of chlorthalidone once per day.

### Claim 27 (depends on 17)

The method of claim 17, wherein the patient is administered 40 mg of azilsartan medoxomil and 25.0 mg of chlorthalidone once per day.

### Claim 28 (depends on 17)

The method of claim 17, wherein the patient is administered 80 mg of azilsartan medoxomil and 25.0 mg of chlorthalidone once per day.

### Claim 29 (depends on 17)

The method of claim 17, wherein the blood pressure is systolic blood pressure.

### Claim 30 (depends on 17)

The method of claim 17, wherein the patient suffers from hypertension, heart failure, stroke, chronic kidney disease, arrhythmia, peripheral artery disease, coronary artery disease or combinations thereof.

### Claim 31 (depends on 17)

The method of claim 17, wherein the hypertension is stage 1 primary systolic hypertension.

### Claim 32 (depends on 17)

The method of claim 17, wherein the hypertension is stage 2 primary systolic hypertension.

### Claim 33 (depends on 1)

The method of claim 1, wherein the patient is administered 20 mg of azilsartan medoxomil and 12.5 mg of chlorthalidone once per day.

### Claim 33 (depends on 1)

The method of claim 1, wherein the patient is administered 40 mg of azilsartan medoxomil and 12.5 mg of chlorthalidone once per day.

### Claim 34 (depends on 1)

The method of claim 1, wherein the patient is administered 80 mg of azilsartan medoxomil and 12.5 mg of chlorthalidone once per day.

### Claim 35 (depends on 17)

The method of claim 17, wherein the patient is administered 20 mg of azilsartan medoxomil and 12.5 mg of chlorthalidone once per day.

### Claim 36 (depends on 17)

The method of claim 17, wherein the patient is administered 40 mg of azilsartan medoxomil and 12.5 mg of chlorthalidone once per day.

### Claim 37 (depends on 17)

The method of claim 17, wherein the patient is administered 80 mg of azilsartan medoxomil and 12.5 mg of chlorthalidone once per day.