18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

A Prospective, Open-label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654745

Enrollment

207

Registered

2008-04-09

Start date

2008-05-31

Completion date

2009-06-30

Last updated

2010-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Type 2 Diabetes

Keywords

blood pressure reduction

Brief summary

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Detailed description

This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

Interventions

DRUGAmlodipine

Amlodipine 5 mg tablets , Daily for 3 weeks;

DRUGamlodipine / olmesartan medoxomil combination

amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg

DRUGHydrochlorothiazide

hydrochlorothiazide tablets, 12.5 mg or 25 mg.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Males or females aged 18 to 80 years. * Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide); Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below: * Fasting plasma glucose \>=126 mg/dL (7.0 mmol/L); or * Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose \>=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or * Two-hour plasma glucose \>=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; * Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP \>130 mmHg and/or DBP \>80 mmHg) on current antihypertensive monotherapy or combination therapy. * Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria. * Females should not be pregnant or lactating and, if applicable, using adequate contraception.

Exclusion criteria

* Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator). * Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) \>=9.0% at screening; * Subjects with type 1 or type 2 diabetes mellitus requiring insulin. * Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.

Design outcomes

Primary

Measure	Time frame	Description
Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment	week 0 - week 12	Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.

Secondary

Measure	Time frame	Description
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment	week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)	Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 0 - weeks 3, 6, 9, 12, 15, 18	change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 0 - weeks 3, 6, 9, 12, 15, 18	change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	week 0 - week 12	number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	week 0 - week 12	number of participants achieving mean daytime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	week 0 - week 12	number of participants achieving mean nighttime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, BP\<120/70, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75, DBP\<70 at week 12
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	week 0 - week 12	number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	week 0 - week 12	number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	week 0 - week 12	number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	week 0 - week 3	number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 3
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	week 0 - week 6	number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 6
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	week 0 - week 9	number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 9
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	week 0 - week 12	number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment	week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)	24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	week 0 - week 18	number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 18
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	week 0 - week 12	number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	week 0 - week 12	number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	week 0 - week 12	number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	week 0 - week 12	number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	week 0 - week 12	number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	week 0 - week 12	number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	week 0 - week 3	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 3
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	week 0 - week 6	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 6
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	week 0 - week 9	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 9
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	week 0 - week 12	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	week 0 - week 15	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 15
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	week 0 - week 18	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 18
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	week 0 - week 15	number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 15

Countries

United States

Participant flow

Recruitment details

Subjects were recruited at 32 sites in the USA from May 12, 2008 to Jan 2, 2009 and 207 enrolled into the active treatment period. The study population consisted of subjects with controlled type 2 diabetes, not requiring insulin therapy, whose hypertension was newly diagnosed or uncontrolled on antihypertensive monotherapy or combination therapy.

Pre-assignment details

Subjects began washout of anti-hypertensive medications during screening then entered placebo run-in lasting 2-3 weeks. Subjects must meet seated blood pressure (BP) criteria at 2 consecutive qualifying visits during the run-in period and satisfy mean daytime ambulatory BP criteria at baseline, one day prior to the first dose of active study drug.

Participants by arm

Arm	Count
Aml + Olm + Hctz amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.	207
Total	207

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	12
Overall Study	Lost to Follow-up	7
Overall Study	poor ABPM, noncompliance, lab MAs	3
Overall Study	Protocol Violation	11
Overall Study	Withdrawal by Subject	10

Baseline characteristics

Characteristic	Aml + Olm + Hctz
Age Continuous	59.1 years STANDARD_DEVIATION 9.5
Body mass index	32.80 mg/m2 STANDARD_DEVIATION 5.947
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	153 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Mean 24-hour ambulatory diastolic blood pressure	81.6 mm Hg STANDARD_DEVIATION 9.76
Mean 24-hour ambulatory systolic blood pressure	144.4 mm Hg STANDARD_DEVIATION 11.74
Pulse rate	73.75 beats per minute STANDARD_DEVIATION 11.909
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	8 Participants
Race (NIH/OMB) Black or African American	35 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	162 Participants
Seated Diastolic Blood Pressure	89.1 mm Hg STANDARD_DEVIATION 10.13
Seated Systolic Blood Pressure	158.8 mm Hg STANDARD_DEVIATION 13.14
Sex: Female, Male Female	122 Participants
Sex: Female, Male Male	85 Participants
Stage of hypertension Stage 1	115 participants
Stage of hypertension Stage 2	92 participants
Years with diabetes	6.44 years STANDARD_DEVIATION 5.978

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	80 / 207	16 / 207	15 / 195	10 / 177	21 / 167	14 / 146	4 / 101
serious Total, serious adverse events	4 / 207	0 / 207	0 / 195	1 / 177	0 / 167	1 / 146	2 / 101

Outcome results

Primary

Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment

Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.

Time frame: week 0 - week 12

Population: ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12.

Arm	Measure	Value (MEAN)	Dispersion
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment	-19.9 mm Hg	Standard Error 0.76

p-value: <0.000195% CI: [-21.5, -18.4]t-test, 2 sided

Secondary

Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment

24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP

Time frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

Arm	Measure	Group	Value (MEAN)	Dispersion
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment	24-hour mean DBP change from baseline	-11.2 mm Hg	Standard Error 0.5
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment	daytime mean DBP change from baseline	-11.7 mm Hg	Standard Error 0.6
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment	nighttime mean DBP change from baseline	-10.4 mm Hg	Standard Error 0.68
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment	last 6 hour mean DBP change from baseline	-10.9 mm Hg	Standard Error 0.64
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment	last 4 hour mean DBP change from baseline	-11.1 mm Hg	Standard Error 0.68
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment	last 2 hour mean DBP change from baseline	-11.5 mm Hg	Standard Error 0.76

Comparison: Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.p-value: <0.000195% CI: [-12.2, -10.3]t-test, 2 sided

Secondary

Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment

Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP

Time frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

Arm	Measure	Group	Value (MEAN)	Dispersion
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment	daytime mean SBP change from baseline	-20.8 mm Hg	Standard Error 0.92
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment	nighttime mean SBP change from baseline	-18.5 mm Hg	Standard Error 0.95
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment	last 6 hours mean SBP change from baseline	-18.9 mm Hg	Standard Error 0.93
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment	last 4 hours mean SBP change from baseline	-19.1 mm Hg	Standard Error 1.02
Aml + Olm + Hctz	Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment	last 2 hours mean SBP change from baseline	-19.5 mm Hg	Standard Error 1.1

Secondary

Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

Time frame: week 0 - weeks 3, 6, 9, 12, 15, 18

Population: Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.

Arm	Measure	Group	Value (MEAN)	Dispersion
Aml + Olm + Hctz	Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 3 mean seDBP change from baseline	-4.1 mm Hg	Standard Error 0.5
Aml + Olm + Hctz	Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 6 mean seDBP change from baseline	-8.2 mm Hg	Standard Error 0.6
Aml + Olm + Hctz	Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 9 mean seDBP change from baseline	-9.7 mm Hg	Standard Error 0.64
Aml + Olm + Hctz	Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 12 mean seDBP change from baseline	-11.2 mm Hg	Standard Error 0.64
Aml + Olm + Hctz	Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 15 mean seDBP change from baseline	-14.4 mm Hg	Standard Error 0.66
Aml + Olm + Hctz	Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 18 mean seDBP change from baseline	-15.1 mm Hg	Standard Error 0.72

Comparison: Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.p-value: <0.000195% CI: [-5.1, -3.1]t-test, 2 sided

Secondary

Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

Time frame: week 0 - weeks 3, 6, 9, 12, 15, 18

Population: Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.

Arm	Measure	Group	Value (MEAN)	Dispersion
Aml + Olm + Hctz	Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 3 mean SBP change from baseline	-10.3 mm Hg	Standard Error 0.87
Aml + Olm + Hctz	Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 6 mean SBP change from baseline	-17.9 mm Hg	Standard Error 0.92
Aml + Olm + Hctz	Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 9 mean SBP change from baseline	-20.0 mm Hg	Standard Error 1.1
Aml + Olm + Hctz	Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 12 mean SBP change from baseline	-23.7 mm Hg	Standard Error 1.02
Aml + Olm + Hctz	Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 15 mean SBP change from baseline	-28.5 mm Hg	Standard Error 1.16
Aml + Olm + Hctz	Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks	week 18 mean SBP change from baseline	-31.1 mm Hg	Standard Error 1.13

Secondary

Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour BP <135/85	140 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour BP <130/80	116 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour BP <125/75	76 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour BP <120/80	59 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour SBP <135	140 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour SBP <130	120 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour SBP <125	92 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour SBP <120	59 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour DBP <85	158 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour DBP <80	146 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12	mean 24-hour DBP <75	121 participants

Secondary

Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean 24-hour SBP reduction >15 & =<30 mm Hg	91 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean 24-hour SBP reduction >30 & =<45 mm Hg	22 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean 24-hour SBP reduction >45 mm Hg	2 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean 24-hour DBP reduction =<10 mm Hg	72 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean 24-hour DBP reduction >10 & =<15 mm Hg	47 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean 24-hour DBP reduction >15 & =<20 mm Hg	31 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean 24-hour SBP reduction =<15 mm Hg	50 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean 24-hour DBP reduction >20 mm Hg	15 participants

Secondary

Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean daytime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime BP < 135/85	116 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime BP < 130/80	83 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime BP < 125/75	48 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime BP < 120/80	42 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime SBP < 135	118 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime SBP < 130	94 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime SBP < 125	67 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime SBP < 120	42 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime DBP < 85	151 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime DBP < 80	124 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12	mean daytime DBP < 75	91 participants

Secondary

Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean daytime SBP reduction >15 & =<30 mm Hg	84 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean daytime SBP reduction >30 & =<45 mm Hg	31 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean daytime SBP reduction >45 mm Hg	3 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean daytime DBP reduction =<10 mm Hg	68 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean daytime DBP reduction >10 & =<15 mm Hg	41 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean daytime DBP reduction >15 & =<20 mm Hg	33 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean daytime DBP reduction >20 mm Hg	23 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean daytime SBP reduction =<15 mm Hg	47 participants

Secondary

Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour BP < 135/85	110 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour BP < 130/80	85 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour BP < 125/75	63 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour BP < 120/80	49 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour SBP < 135	115 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour SBP < 130	92 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour SBP < 125	76 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour SBP < 120	51 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour DBP < 85	145 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour DBP < 80	125 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 2 hour DBP < 75	94 participants

Secondary

Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 2 hour DBP reduction =<10 mm Hg	77 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 2 hour DBP reduction >10 & =<15 mm Hg	28 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 2 hour DBP reduction >15 & =<20 mm Hg	29 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 2 hour DBP reduction >20 mm Hg	31 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 2 hour SBP reduction =<15 mm Hg	63 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 2 hour SBP reduction >15 & =<30 mm Hg	62 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 2 hour SBP reduction >30 & =<45 mm Hg	35 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 2 hour SBP reduction >45 mm Hg	5 participants

Secondary

Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour BP < 135/85	129 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour SBP < 120	72 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour DBP < 85	150 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour DBP < 80	137 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour DBP < 75	120 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour BP < 130/80	107 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour BP < 125/75	92 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour BP < 120/80	72 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour SBP < 135	131 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour SBP < 130	114 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 4 hour SBP < 125	102 participants

Secondary

Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions

number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	mean last 4 hour SBP reduction =<15 mm Hg	67 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	mean last 4 hour SBP reduction >15 & =<30 mm Hg	65 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	mean last 4 hour SBP reduction >30 & =<45 mm Hg	28 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	mean last 4 hour SBP reduction >45 mm Hg	5 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	mean last 4 hour DBP reduction >10 & =<15 mm Hg	36 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	mean last 4 hour DBP reduction >15 & =<20 mm Hg	25 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	mean last 4 hour DBP reduction =<10 mm Hg	76 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions	mean last 4 hour DBP reduction >20 mm Hg	28 participants

Secondary

Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12

number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour BP < 130/80	124 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour BP < 125/75	101 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour BP < 120/80	85 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour SBP < 135	143 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour SBP < 125	108 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour SBP < 120	85 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour DBP < 85	157 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour DBP < 80	146 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour DBP < 75	130 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour BP < 135/85	135 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12	mean last 6 hour SBP < 130	127 participants

Secondary

Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 6 hour SBP reduction =<15 mm Hg	61 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 6 hour SBP reduction >30 & =<45 mm Hg	23 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 6 hour SBP reduction >45 mm Hg	5 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 6 hour DBP reduction =<10 mm Hg	76 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 6 hour DBP reduction >10 & =<15 mm Hg	41 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 6 hour DBP reduction >15 & =<20 mm Hg	27 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 6 hour DBP reduction >20 mm Hg	21 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean last 6 hour SBP reduction >15 & =<30 mm Hg	76 participants

Secondary

Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12

number of participants achieving mean nighttime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, BP\<120/70, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75, DBP\<70 at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime SBP < 120	112 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime DBP < 85	160 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime DBP < 80	158 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime DBP < 75	147 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime DBP < 70	124 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime BP < 135/85	152 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime BP < 130/80	137 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime BP < 125/75	119 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime BP < 120/80	112 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime BP < 120/70	101 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime SBP < 135	154 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime SBP < 130	139 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12	mean nighttime SBP < 125	123 participants

Secondary

Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean nighttime SBP reduction >45 mm Hg	5 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean nighttime DBP reduction =<10 mm Hg	80 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean nighttime SBP reduction >10 & =<15 mm Hg	41 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean nighttime SBP reduction >15 & =<20 mm Hg	21 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean nighttime DBP reduction >20 mm Hg	23 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean nighttime SBP reduction =<15 mm Hg	60 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean nighttime SBP reduction >15 & =<30 mm Hg	79 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12	mean nighttime SBP reduction >30 & =<45 mm Hg	21 participants

Secondary

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12

number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg & \<= 30 mmHg, SBP reduction \> 30 mmHg & \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg & \<= 15 mmHg, DBP reduction \> 15 mmHg & \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	mean seated SBP reduction =<15 mm Hg	48 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	mean seated SBP reduction >15 & =<30 mm Hg	73 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	mean seated SBP reduction >30 & =<45 mm Hg	45 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	mean seated SBP reduction >45 mm Hg	11 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	mean seated DBP reduction =<10 mm Hg	85 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	mean seated DBP reduction >10 & =<15 mm Hg	42 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	mean seated DBP reduction >15 & =<20 mm Hg	27 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12	mean seated DBP reduction >20 mm Hg	23 participants

Secondary

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15

Time frame: week 0 - week 15

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	mean seated SBP reduction >30 & =<45 mm Hg	55 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	mean seated SBP reduction >45 mm Hg	20 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	mean seated DBP reduction =<10 mm Hg	52 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	mean seated DBP reduction >10 & =<15 mm Hg	45 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	mean seated DBP reduction >15 & =<20 mm Hg	32 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	mean seated DBP reduction >20 mm Hg	43 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	mean seated SBP reduction =<15 mm Hg	31 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15	mean seated SBP reduction >15 & =<30 mm Hg	66 participants

Secondary

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18

Time frame: week 0 - week 18

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	mean seated SBP reduction =<15 mm Hg	22 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	mean seated SBP reduction >15 & =<30 mm Hg	53 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	mean seated SBP reduction >30 & =<45 mm Hg	64 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	mean seated SBP reduction >45 mm Hg	25 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	mean seated DBP reduction =<10 mm Hg	50 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	mean seated DBP reduction >10 & =<15 mm Hg	33 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	mean seated DBP reduction >15 & =<20 mm Hg	29 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18	mean seated DBP reduction >20 mm Hg	52 participants

Secondary

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3

Time frame: week 0 - week 3

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	mean seated SBP reduction =<15 mm Hg	131 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	mean seated SBP reduction >15 & =<30 mm Hg	62 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	mean seated SBP reduction >30 & =<45 mm Hg	6 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	mean seated SBP reduction >45 mm Hg	2 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	mean seated DBP reduction =<10 mm Hg	163 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	mean seated DBP reduction >10 & =<15 mm Hg	25 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	mean seated DBP reduction >15 & =<20 mm Hg	10 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3	mean seated DBP reduction >20 mm Hg	3 participants

Secondary

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6

Time frame: week 0 - week 6

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	mean seated SBP reduction =<15 mm Hg	69 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	mean seated SBP reduction >15 & =<30 mm Hg	90 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	mean seated SBP reduction >30 & =<45 mm Hg	31 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	mean seated DBP reduction >20 mm Hg	15 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	mean seated SBP reduction >45 mm Hg	2 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	mean seated DBP reduction =<10 mm Hg	120 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	mean seated DBP reduction >10 & =<15 mm Hg	33 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6	mean seated DBP reduction >15 & =<20 mm Hg	24 participants

Secondary

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9

Time frame: week 0 - week 9

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	mean seated SBP reduction =<15 mm Hg	72 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	mean seated SBP reduction >15 & =<30 mm Hg	69 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	mean seated SBP reduction >30 & =<45 mm Hg	34 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	mean seated SBP reduction >45 mm Hg	9 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	mean seated DBP reduction =<10 mm Hg	100 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	mean seated DBP reduction >10 & =<15 mm Hg	43 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	mean seated DBP reduction >15 & =<20 mm Hg	18 participants
Aml + Olm + Hctz	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9	mean seated DBP reduction >20 mm Hg	23 participants

Secondary

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12

number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12

Time frame: week 0 - week 12

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean SBP < 125	46 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean SBP < 120	28 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean BP < 135/85	86 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean BP < 130/80	61 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean BP < 125/75	33 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean BP < 120/80	28 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean SBP < 135	93 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean SBP < 130	70 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean DBP < 85	134 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean DBP < 80	105 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12	mean DBP < 75	74 participants

Secondary

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15

Time frame: week 0 - week 15

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean BP < 135/85	114 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean SBP < 135	116 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean BP < 130/80	83 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean BP < 125/75	51 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean BP < 120/80	45 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean SBP < 130	95 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean SBP < 125	69 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean SBP < 120	48 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean DBP < 85	153 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean DBP < 80	122 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15	mean DBP < 75	96 participants

Secondary

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18

Time frame: week 0 - week 18

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean BP < 135/85	117 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean BP < 130/80	87 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean BP < 125/75	56 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean BP < 120/80	49 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean SBP < 135	123 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean SBP < 130	101 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean SBP < 125	74 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean SBP < 120	51 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean DBP < 85	147 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean DBP < 80	128 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18	mean DBP < 75	94 participants

Secondary

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3

Time frame: week 0 - week 3

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean BP < 135/85	31 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean BP < 130/80	10 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean BP < 125/75	4 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean BP < 120/80	2 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean SBP < 135	41 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean SBP < 130	17 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean SBP < 125	9 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean SBP < 120	2 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean DBP < 85	99 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean DBP < 80	58 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3	mean DBP < 75	29 participants

Secondary

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6

Time frame: week 0 - week 6

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean SBP < 130	48 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean SBP < 125	31 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean SBP < 120	14 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean DBP < 85	127 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean BP < 135/85	61 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean BP < 130/80	36 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean BP < 125/75	18 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean BP < 120/80	13 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean SBP < 135	73 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean DBP < 80	91 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6	mean DBP < 75	48 participants

Secondary

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9

Time frame: week 0 - week 9

Arm	Measure	Group	Value (NUMBER)
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean SBP < 135	82 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean BP < 135/85	76 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean BP < 130/80	47 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean BP < 125/75	25 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean BP < 120/80	19 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean SBP < 130	61 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean SBP < 125	41 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean SBP < 120	20 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean DBP < 85	132 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean DBP < 80	95 participants
Aml + Olm + Hctz	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9	mean DBP < 75	64 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment

Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment

Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment

Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks

Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12

Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12

Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12

Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12

Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions

Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12

Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12

Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6

Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6

Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9