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

NCT ID: NCT01005290

Last Updated: 2012-07-26

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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cardiovascular fixed dose combination pill hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Combination pill

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.

Group Type EXPERIMENTAL

Combination pill

Intervention Type DRUG

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.

Ramipril

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.

Group Type ACTIVE_COMPARATOR

Ramipril

Intervention Type DRUG

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.

Interventions

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Combination pill

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.

Intervention Type DRUG

Ramipril

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.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferrer Internacional S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valentin Fuster, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P-080646-01

Identifier Type: -

Identifier Source: org_study_id