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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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title XOMA 985 Amlodipine Besylate (AMLb) Perindopril Erbumine (PERe)
Hide 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
Arm/Group Title XOMA 985 Amlodipine Besylate (AMLb) Perindopril Erbumine (PERe) Total
Hide 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
Hide 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
279 280 278 837
1.Primary Outcome
Title Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
Hide Description [Not Specified]
Time Frame Day 0 to Day 42
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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).
Hide Description [Not Specified]
Time Frame Day 0 to Day 42
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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]
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)
Hide 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   --/--      --/--      --/--    
Hide 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
Hide 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
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