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

Hypertension Clinical Trial

Official title:

Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Interaction Study to Evaluate the Effect of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin and Ramipril (Cardiovascular Fixed Dose Combination Pill) on Blood Pressure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01005290
• Other study ID #: P-080646-01
• Status: Terminated
• Phase: Phase 2
• First received: October 22, 2009
• Last updated: June 20, 2012
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2012
• Source: Ferrer Internacional S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• 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
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.

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ferrer Internacional S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Days 7 and 36 of Period 1 and days 49 and 85 of Period 2	No
Secondary	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	Days 7 and 36 of Period 1 and days 49 and 85 of Period 2	No