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

Phase 2

Terminated

• Conditions: Hypertension
• Interventions: Drug: Combination pill; Drug: Ramipril

• Registration Number: NCT01005290
• Lead Sponsor: Ferrer Internacional S.A.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2012-03-30
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-20
• Last Update Submitted: 2012-06-20
• Results First Posted: 2012-07-26
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Combination pill	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.
Ramipril	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.

Primary Outcome Measures

Name	Time	Method
Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.	Days 7 and 36 of Period 1 and days 49 and 85 of Period 2	Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.

Secondary Outcome Measures

Name	Time	Method
Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period	Days 7 and 36 of Period 1 and days 49 and 85 of Period 2	Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period

Trial Locations

Locations (1)

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States