Clinical trial NCT01556997: Perindopril Amlodipine for the Treatment of Hypertension
Official title: Perindopril Amlodipine for the Treatment of Hypertension (PATH): A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Efficacy and Safety of a Fixed-Dose Combination of Perindopril Arginine Plus Amlodipine Besylate Versus Perindopril Erbumine and Amlodipine Besylate in Subjects With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Hypertension
Essential Hypertension
Lead sponsor: Symplmed Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 837
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.


Eligibility criteria: Inclusion Criteria:

* Essential hypertension
* For female subjects, a negative serum pregnancy test
* Ability to provide written informed consent

Exclusion Criteria:

* Night shift workers whose work hours include midnight to 4:00 a.m.
* Secondary hypertension
* An arm size that precludes the use of the digital blood pressure monitor cuff (arm size \> 42 cm)
* Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
* Female subjects who are pregnant, planning to become pregnant
* History of malignancy within 5 years
* Primary aldosteronism
* Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve
* Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina
* Known hypersensitivity to any component of the study drugs

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
timeFrame: Day 0 to Day 42
Secondary outcomes:
measure: Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
timeFrame: Day 0 to Day 42
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Greenbrae
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Deland
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Gurnee
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Olive Branch
country: United States
state: Mississippi
city: Butte
country: United States
state: Montana
city: Berlin
country: United States
state: New Jersey
city: Greensboro
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Mount Pleasant
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
References: