Perindopril Amlodipine for the Treatment of Hypertension (PATH)

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ClinicalTrials.gov Identifier: NCT01556997

Recruitment Status : Completed

First Posted : March 19, 2012

Results First Posted : August 25, 2015

Last Update Posted : September 28, 2015

Sponsor:

Information provided by (Responsible Party):

Symplmed Pharmaceuticals LLC

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Essential Hypertension
Interventions	Drug: XOMA 985 Drug: Amlodipine Besylate Drug: Perindopril Erbumine
Enrollment	837

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	XOMA 985	Amlodipine Besylate (AMLb)	Perindopril Erbumine (PERe)
Arm/Group Description	fixed-dose combination of perindopr...	Amlodipine Besylate: AMLb capsule t...	Perindopril Erbumine: PERe capsule ...
Arm/Group Description	fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks	Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks	Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
Period Title: Overall Study
Started	279	280	278
Completed	253	252	246
Not Completed	26	28	32
Reason Not Completed
Adverse Event	10	12	12
Lost to Follow-up	6	6	4
Physician Decision	1	1	1
Withdrawal by Subject	7	6	8
Other	2	3	7

Baseline Characteristics

Arm/Group Title		XOMA 985	Amlodipine Besylate (AMLb)	Perindopril Erbumine (PERe)	Total
Arm/Group Description		fixed-dose combination of perindopr...	Amlodipine Besylate: AMLb capsule t...	Perindopril Erbumine: PERe capsule ...	Total of all reporting groups
Arm/Group Description		fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks	Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks	Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks	Total of all reporting groups
Overall Number of Baseline Participants		279	280	278	837
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	279 participants	280 participants	278 participants	837 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	261 93.5%	262 93.6%	254 91.4%	777 92.8%
	>=65 years	18 6.5%	18 6.4%	24 8.6%	60 7.2%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	279 participants	280 participants	278 participants	837 participants
	Female	134 48.0%	130 46.4%	143 51.4%	407 48.6%
	Male	145 52.0%	150 53.6%	135 48.6%	430 51.4%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	279 participants	280 participants	278 participants	837 participants
	Hispanic or Latino	47 16.8%	43 15.4%	52 18.7%	142 17.0%
	Not Hispanic or Latino	232 83.2%	237 84.6%	226 81.3%	695 83.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	279 participants	280 participants	278 participants	837 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	2 0.7%	1 0.4%	1 0.4%	4 0.5%
	Native Hawaiian or Other Pacific Islander	3 1.1%	0 0.0%	1 0.4%	4 0.5%
	Black or African American	95 34.1%	96 34.3%	96 34.5%	287 34.3%
	White	179 64.2%	181 64.6%	180 64.7%	540 64.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	2 0.7%	0 0.0%	2 0.2%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	279 participants	280 participants	278 participants	837 participants
Black		95	96	96	287
Non-black		184	184	182	550
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	279 participants	280 participants	278 participants	837 participants
United States		279	280	278	837

Outcome Measures

1.Primary Outcome


Title	Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Day 0 to Day 42

Outcome Measure Data

Analysis Population Description

The Analysis Population for the Primary Outcome (Change from baseline to end of treatment in the mean seated trough cuff diastolic blood pressure (DBP)) consists of the Intent-to-treat population for the study


Arm/Group Title	XOMA 985	Amlodipine Besylate (AMLb)	Perindopril Erbumine (PERe)
Arm/Group Description:	fixed-dose combination of perindopr...	Amlodipine Besylate: AMLb capsule t...	Perindopril Erbumine: PERe capsule ...
Arm/Group Description:	fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks	Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks	Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
Overall Number of Participants Analyzed	271	275	274
Mean (Standard Deviation) Unit of Measure: mmHg
	-15.7 (8.38)	-13.2 (8.33)	-9.5 (8.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XOMA 985, Amlodipine Besylate (AMLb), Perindopril Erbumine (PERe)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.025
	Comments	The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.
	Method	ANCOVA
	Comments	[Not Specified]

2.Secondary Outcome


Title	Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Day 0 to Day 42

Outcome Measure Data

Analysis Population Description

The Analysis Population for the Secondary Outcome (Change from baseline to end of treatment in the mean seated trough cuff systolic blood pressure (SBP)) consists of the Intent-to-treat population for the study


Arm/Group Title	XOMA 985	Amlodipine Besylate (AMLb)	Perindopril Erbumine (PERe)
Arm/Group Description:	fixed-dose combination of perindopr...	Amlodipine Besylate: AMLb capsule t...	Perindopril Erbumine: PERe capsule ...
Arm/Group Description:	fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks	Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks	Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
Overall Number of Participants Analyzed	271	275	274
Mean (Standard Deviation) Unit of Measure: mmHg
	-23.4 (13.86)	-19.6 (15.62)	-13.4 (14.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XOMA 985, Amlodipine Besylate (AMLb), Perindopril Erbumine (PERe)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.025
	Comments	The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.
	Method	ANCOVA
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	AE reporting began with Visit 1 and continued through 14 days after last dose, unless an unresolved AE was still being followed. At each evaluation, the Investigator determined whether any AEs occurred based on the criteria and definition of an AE or SAE. AEs may have been directly observed, elicited by Investigator, or volunteered by subjects.

Arm/Group Title	XOMA 985		Amlodipine Besylate (AMLb)		Perindopril Erbumine (PERe)
Arm/Group Description	fixed-dose combination of perindopr...		Amlodipine Besylate: AMLb capsule t...		Perindopril Erbumine: PERe capsule ...
Arm/Group Description	fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks		Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks		Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
All-Cause Mortality
	XOMA 985		Amlodipine Besylate (AMLb)		Perindopril Erbumine (PERe)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	XOMA 985		Amlodipine Besylate (AMLb)		Perindopril Erbumine (PERe)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/279 (0.36%)		3/280 (1.07%)		2/278 (0.72%)
Cardiac disorders
Acute Myocardial Infarction ^† 1	0/279 (0.00%)	0	1/280 (0.36%)	1	0/278 (0.00%)	0
Gastrointestinal disorders
Lip Swelling ^† 1	0/279 (0.00%)	0	0/280 (0.00%)	0	1/278 (0.36%)	1
Gastrointestinal Hemorrhage ^† 1	0/279 (0.00%)	0	1/280 (0.36%)	1	0/278 (0.00%)	0
Musculoskeletal and connective tissue disorders
Osteoarthritis ^† 1	0/279 (0.00%)	0	1/280 (0.36%)	1	0/278 (0.00%)	0
Renal and urinary disorders
Renal Failure Acute ^† 1	0/279 (0.00%)	0	0/280 (0.00%)	0	1/278 (0.36%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism ^† 1	1/279 (0.36%)	1	0/280 (0.00%)	0	0/278 (0.00%)	0
Vascular disorders
Hypotension ^† 1	0/279 (0.00%)	0	0/280 (0.00%)	0	1/278 (0.36%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 12.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	XOMA 985		Amlodipine Besylate (AMLb)		Perindopril Erbumine (PERe)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	75/279 (26.88%)		68/280 (24.29%)		53/278 (19.06%)
Gastrointestinal disorders
Diarrhea ^† 1	3/279 (1.08%)		1/280 (0.36%)		5/278 (1.80%)
Nausea ^† 1	2/279 (0.72%)		2/280 (0.71%)		4/278 (1.44%)
General disorders
Edema peripheral ^† 1	20/279 (7.17%)		35/280 (12.50%)		1/278 (0.36%)
Fatigue ^† 1	5/279 (1.79%)		2/280 (0.71%)		4/278 (1.44%)
Infections and infestations
Nasopharyngitis ^† 1	3/279 (1.08%)		1/280 (0.36%)		0/278 (0.00%)
Urinary tract infection ^† 1	4/279 (1.43%)		0/280 (0.00%)		0/278 (0.00%)
Investigations
Alanine amniotransferase increased ^† 1	0/279 (0.00%)		0/280 (0.00%)		4/278 (1.44%)
Aspartate amniotransferase increased ^† 1	1/279 (0.36%)		0/280 (0.00%)		3/278 (1.08%)
Blood potassium increased ^† 1	0/279 (0.00%)		0/280 (0.00%)		3/278 (1.08%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	2/279 (0.72%)		2/280 (0.71%)		3/278 (1.08%)
Back pain ^† 1	3/279 (1.08%)		2/280 (0.71%)		1/278 (0.36%)
Musculoskeletal pain ^† 1	2/279 (0.72%)		0/280 (0.00%)		3/278 (1.08%)
Nervous system disorders
Headache ^† 1	7/279 (2.51%)		8/280 (2.86%)		8/278 (2.88%)
Dizziness ^† 1	7/279 (2.51%)		3/280 (1.07%)		4/278 (1.44%)
Renal and urinary disorders
Hematuria ^† 1	2/279 (0.72%)		3/280 (1.07%)		1/278 (0.36%)
Pollakiuria ^† 1	1/279 (0.36%)		4/280 (1.43%)		0/278 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	9/279 (3.23%)		2/280 (0.71%)		8/278 (2.88%)
Skin and subcutaneous tissue disorders
Erythema ^† 1	3/279 (1.08%)		0/280 (0.00%)		1/278 (0.36%)
Rash ^† 1	1/279 (0.36%)		3/280 (1.07%)		0/278 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 12.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Jeff Feldstein, Sr. Vice President and CMO
Organization:	Symplmed Pharmaceuticals LLC
Phone:	888-552-9769
EMail:	feldstein@symplmed.com

Layout table for additonal information

Responsible Party:	Symplmed Pharmaceuticals LLC
ClinicalTrials.gov Identifier:	NCT01556997
Other Study ID Numbers:	X985400
First Submitted:	March 15, 2012
First Posted:	March 19, 2012
Results First Submitted:	July 28, 2015
Results First Posted:	August 25, 2015
Last Update Posted:	September 28, 2015

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