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CompletedNCT01556997PATHUpdated Sep 28, 2015Results posted

Perindopril Amlodipine for the Treatment of Hypertension

A Phase 3 interventional study of XOMA 985 and Amlodipine Besylate in Essential Hypertension, sponsored by Symplmed Pharmaceuticals LLC. Completed at 48 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-28.

Sponsored by Symplmed Pharmaceuticals LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
837
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Essential Hypertension

Keywords

  • Hypertension
  • Essential Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 837 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

This is the only study on the registry with Symplmed Pharmaceuticals LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
837 participants (actual)

Study arms

  • Experimental
    XOMA 985

    fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)

    Drug: XOMA 985

  • Active comparator
    Amlodipine Besylate (AMLb)

    Drug: Amlodipine Besylate

  • Active comparator
    Perindopril Erbumine (PERe)

    Drug: Perindopril Erbumine

Interventions

  • DrugXOMA 985

    PERa/AMLb capsule taken once daily by mouth for six weeks

  • DrugAmlodipine Besylate

    AMLb capsule taken once daily by mouth for six weeks

  • DrugPerindopril Erbumine

    PERe capsule taken once daily by mouth for six weeks

06

What researchers measure

Primary outcomes

  1. Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).

    Time frame: Day 0 to Day 42

Secondary outcomes

  1. Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).

    Time frame: Day 0 to Day 42

07

Results

Posted Aug 25, 2015

Participant flow

Participant flow — Overall Study
MilestoneXOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)
Started279280278
Completed253252246
Not completed262832
Withdrew: Adverse event101212
Withdrew: Lost to follow-up664
Withdrew: Physician decision111
Withdrew: Withdrawal by subject768
Withdrew: Other237

Outcome measures

PrimaryChange From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
Time frame:
Day 0 to Day 42
Reported as:
Mean · mmHg
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).
mmHgXOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).-15.7 ± 8.38-13.2 ± 8.33-9.5 ± 8.77
Statistical analysis
  • XOMA 985 vs Amlodipine Besylate (AMLb) vs Perindopril Erbumine (PERe) · ANCOVA · p = 0.025 (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.)
SecondaryChange From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
Time frame:
Day 0 to Day 42
Reported as:
Mean · mmHg
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).
mmHgXOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)
Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).-23.4 ± 13.86-19.6 ± 15.62-13.4 ± 14.66
Statistical analysis
  • XOMA 985 vs Amlodipine Besylate (AMLb) vs Perindopril Erbumine (PERe) · ANCOVA · p = 0.025 (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.)

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
XOMA 985—1/279 (0.4%)75/279 (26.9%)
Amlodipine Besylate (AMLb)—3/280 (1.1%)68/280 (24.3%)
Perindopril Erbumine (PERe)—2/278 (0.7%)53/278 (19.1%)
Most frequent serious events
Most frequent serious events
EventXOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)
Lip SwellingGastrointestinal disorders0/2790/2801/278
Renal Failure AcuteRenal and urinary disorders0/2790/2801/278
HypotensionVascular disorders0/2790/2801/278
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders1/2790/2800/278
OsteoarthritisMusculoskeletal and connective tissue disorders0/2791/2800/278
Gastrointestinal HemorrhageGastrointestinal disorders0/2791/2800/278
Acute Myocardial InfarctionCardiac disorders0/2791/2800/278
Most frequent other events
Showing 10 of 19
Most frequent other events
EventXOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)
Edema peripheralGeneral disorders20/27935/2801/278
CoughRespiratory, thoracic and mediastinal disorders9/2792/2808/278
HeadacheNervous system disorders7/2798/2808/278
DizzinessNervous system disorders7/2793/2804/278
DiarrheaGastrointestinal disorders3/2791/2805/278
FatigueGeneral disorders5/2792/2804/278
NauseaGastrointestinal disorders2/2792/2804/278
Alanine amniotransferase increasedInvestigations0/2790/2804/278
Urinary tract infectionInfections and infestations4/2790/2800/278
PollakiuriaRenal and urinary disorders1/2794/2800/278

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)XOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)Total
<=18 years0000
Between 18 and 65 years261262254777
>=65 years18182460
Sex: Female, Male
Sex: Female, Male(Participants)XOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)Total
Female134130143407
Male145150135430
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)XOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)Total
Hispanic or Latino474352142
Not Hispanic or Latino232237226695
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)XOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)Total
American Indian or Alaska Native0000
Asian2114
Native Hawaiian or Other Pacific Islander3014
Black or African American959696287
White179181180540
More than one race0000
Unknown or Not Reported0202
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)XOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)Total
Black959696287
Non-black184184182550
Region of Enrollment
Region of Enrollment(participants)XOMA 985Amlodipine Besylate (AMLb)Perindopril Erbumine (PERe)Total
United States279280278837
08

Study locations

48 sites
  • Huntsville, Alabama, United States
  • Muscle Shoals, Alabama, United States
  • Glendale, Arizona, United States
  • Greenbrae, California, United States
  • Los Angeles, California, United States
  • Santa Ana, California, United States
  • Denver, Colorado, United States
  • Deland, Florida, United States
  • Ft. Lauderdale, Florida, United States
  • Miami, Florida, United States
  • Palm Harbor, Florida, United States
  • Port Orange, Florida, United States
  • Marietta, Georgia, United States
  • Gurnee, Illinois, United States
  • Indianapolis, Indiana, United States
  • Wichita, Kansas, United States
  • Louisville, Kentucky, United States
  • Metairie, Louisiana, United States
  • Auburn, Maine, United States
  • Baltimore, Maryland, United States
  • Olive Branch, Mississippi, United States
  • Butte, Montana, United States
  • Berlin, New Jersey, United States
  • Greensboro, North Carolina, United States
  • Hickory, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Kettering, Ohio, United States
  • Lyndhurst, Ohio, United States
  • Marion, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Tulsa, Oklahoma, United States
  • Eugene, Oregon, United States
  • Mount Pleasant, South Carolina, United States
  • Simpsonville, South Carolina, United States
  • Bristol, Tennessee, United States
  • Austin, Texas, United States
  • Corpus Christi, Texas, United States
  • Dallas, Texas, United States
  • Ft. Worth, Texas, United States
  • Houston, Texas, United States
  • Katy, Texas, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
  • Norfolk, Virginia, United States
  • Richmond, Virginia, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01556997
Lead sponsor
Symplmed Pharmaceuticals LLC
Responsible party
Sponsor
First posted
Mar 19, 2012
Start date
Feb 2012
Primary completion
Feb 2013
Completion
Feb 2013
Results posted
Aug 25, 2015
Last update
Sep 28, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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