A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure

Phase 2TerminatedNCT01005290

Ferrer Internacional S.A.38 enrolled

Overview

The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Combination pillDRUG

A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.

RamiprilDRUG

A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects will be ≥18 years old * Previously untreated systolic pressure result of ≥120\<160 mmHg and diastolic pressure result of ≥80\<100 mmHg Exclusion Criteria: * Subjects must not have previously received any anti-hypertensive medication * must not have a systolic pressure \<120 mmHg or ≥160 mmHg and diastolic pressure result of \<80 mmHg or ≥100 mmHg * must not have had a previous coronary artery bypass graft (CABG) * must not have had a previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent * must not have severe congestive heart failure (New York Heart Classification \[NYHC\] III-IV).

Locations (1)

Mount Sinai Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.

Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.

Time frame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2

Secondary Outcomes

Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period

Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period

Time frame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2

Data from ClinicalTrials.gov

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