A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure

Daiichi Sankyo999 enrolled

Overview

The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

999

Conditions

Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \>= to 18 years of age * Hypertension uncontrolled on current monotherapy * Females: * negative serum pregnancy test at screening * post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control Exclusion Criteria: * Pregnant females * Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene * Diabetes requiring insulin * Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment * History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months * History of Class III or IV congestive heart failure * History of stroke or transient ischemic attack within the last 1 year

Locations (72)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Green Valley, Arizona, United States

Unnamed facility

Mesa, Arizona, United States

Unnamed facility

Sierra Vista, Arizona, United States

Unnamed facility

Tempe, Arizona, United States

Unnamed facility

Outcomes

Primary Outcomes

The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks

Time frame: baseline to 12 weeks

Secondary Outcomes

The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks

Time frame: baseline to 12 weeks

The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks

Time frame: Baseline to 12 and 20 weeks

Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.

Time frame: Baseline to 12 weeks

Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.

Time frame: Baseline to 20 weeks

Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.

Time frame: Baseline to 12 weeks

Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.

Time frame: Baseline to 20 weeks

Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.

Time frame: Baseline to 12 weeks

Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.

Time frame: Baseline to 20 weeks

Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.

Time frame: Baseline to 12 weeks

Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values

Time frame: Baseline to 20 weeks

Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Time frame: Baseline to 4, 8, 12, 16, 20 weeks

Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Time frame: Baseline to 12 weeks

Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Time frame: Baseline to 20 weeks

Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Time frame: Baseline to 12 weeks

Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Time frame: Baseline to 20 weeks

Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Time frame: Baseline to 12 weeks

Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Time frame: Baseline to 20 weeks

Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Time frame: Baseline to 12 weeks

Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Time frame: Baseline to 20 weeks

Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Time frame: Baseline to 12 weeks

Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Time frame: Baseline to 20 weeks

Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Time frame: Baseline to 12 weeks

Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Time frame: Baseline to 20 weeks