OLMETREAT: Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension

• Sponsor: Sankyo Pharma Gmbh (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00311155
• Collaborator: (none)
• Enrollment: 694
• Locations: 79
• Arm: 1
• Duration (Months): 25
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 694 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 1 Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary; Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.

Outcome Measures

Primary Outcome Measures

1. The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved. [Baseline to ≤20 weeks]

   For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.

Secondary Outcome Measures

1. Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved [Baseline to ≤20 weeks]

   Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients.

2. Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved. [Baseline to ≤20 weeks]

   Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.

3. Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved [Baseline to ≤20 weeks]

   Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough

4. Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment [Baseline to ≤20 weeks]

5. Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment [Baseline to ≤20 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female patients age greater than or equal to 18 years with mild to moderate hypertension.

• Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough.

Exclusion Criteria:

• Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception.

• Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases.

• Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack.

• Patients with clinically significant elevations in laboratory values at Screening Visit.

• Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.

• Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fulpmes		Austria	6166
2	University Klinik, F. Innere Medizin	Innsbruck		Austria	6020
3		Innsbruck		Austria	6020
4		Kundl		Austria	6250
5	Diakonissen-Krankenhaus Hospital	Salzburg-Aigen		Austria	5026
6		Salzburg		Austria	5020
7		Bruxelles		Belgium	1080
8		Mechelen		Belgium	2800
9	Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care	Seraing		Belgium	4100
10	Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan	Temse		Belgium	9140
11		Ancerville		France	55170
12		Bourges		France	18000
13		Derval		France	44590
14		Grenoble		France	38100
15		Lille		France	59037
16		Montrevel en Bresse		France	01340
17		Pouilly en Auxois		France	21320
18		Poussan		France	34560
19		Sorcy Saint Martin		France	55190
20		St Aubin des Châteaux		France	44110
21		St Etienne de Montluc		France	44360
22		St Priest		France	69800
23		Strasbourg		France	67000
24		Yerres		France	91330
25		Annweiler		Germany	76855
26		Balve		Germany	58802
27		Bammental		Germany	69245
28	Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I	Bielefeld		Germany	33617
29	Uniklinik Bonn	Bonn		Germany	53111
30		Goch		Germany	47574
31		Haag		Germany	83527
32		Hamburg		Germany	20148
33		Heidelberg (Neuenheim)		Germany	69120
34		Heidelberg		Germany	69115
35		Mühldorf / Inn		Germany	84453
36		Schwenningen		Germany	78054
37		VS-Villingen		Germany	78050
38		Weyhe		Germany	28844
39	Ospedale Regina Apostolorum	Albano Laziale (RM)		Italy	00041
40	Ospedale C.G. Mazzoni	Ascoli Piceno		Italy	63100
41	Ospedale Nuovo Cutroni	Barcellona Pozzo di Gotto (ME)		Italy	98051
42	Casa di Cura "La Madonnina"	Bari		Italy	70124
43	Ospedale San Sebastiano	Caserta		Italy	81100
44	Ospedale Vittorio Emanuele	Catania		Italy	95124
45	Università degli Studi "G. D'Annunzio"	Chieti Scalo		Italy	66013
46	Azienda Ospedaliera "Madonna delle Grazie"	Matera		Italy	75100
47	Ospedale San Paolo	Milano		Italy	20142
48	Ospedale San Carlo Borromeo	Milano		Italy	20153
49	Presidio Ospedaliero San Lorenzo	Palermo		Italy	90146
50	Presidio Ospedaliero di Portogruaro	Portogruaro (VE)		Italy	30026
51	Azienda Policlinico Universitario a Gestione Diret	Udine		Italy	33100
52	Maxima Medisch Centrum	Eindhoven		Netherlands	5631 BM
53	H. Elvas	Elvas		Netherlands	7350-954
54		Hertogenbosch		Netherlands	5216 GC
55		Hilversum		Netherlands	1214 JR
56		Lieshout		Netherlands	5737 CB
57		Waalwijk		Netherlands	5144 CB
58	H. Almada	Almada Almada		Portugal	2801-951
59	Hospital Fernando da Fonseca	Amadora Amadora		Portugal	2720-276
60	Hospital de. S. Marta	Lisboa Lisboa		Portugal	1169-024
61	Zentrum Oberdorf	Affoltern am Albis		Switzerland	8910
62		Bellinzona		Switzerland	6500
63		Gland		Switzerland	1196
64		Petit-Lancy		Switzerland	1213
65	Praxis Dreispitz	Zurich		Switzerland	8050
66	The Atherstone Surgery	Atherstone		United Kingdom	CV9 1EU
67	The Medical Centre	Birmingham		United Kingdom	B37 7TR
68	Waterloo Medical Centre	Blackpool		United Kingdom	FY4 3AD
69	Rowden Surgery	Chippenham		United Kingdom	SN15 2SB
70	The Gables Medical Centre	Coventry		United Kingdom	CV6 4DD
71	Bridge Medical Centre	Crawley		United Kingdom	RH10 1LL
72	Homefield Surgery	Exeter		United Kingdom	EX1 2QS
73	Woodside Health Centre	Glasgow		United Kingdom	G20 7LR
74	Castle Milk Health Centre	Glasgow		United Kingdom	G45 9 AW
75	Division of Cardiovascular and Endocrine Sciences	Manchester		United Kingdom	M13 9NT
76	University of Manchester	Manchester		United Kingdom	M13 9WL
77	Oakside Surgery	Plymouth		United Kingdom	PL5 3PY
78	Norwood Medical Centre	Sheffield		United Kingdom	S5 7HD
79	Lovemead Group Practice	Trowbridge		United Kingdom	BA14 7EG

Sponsors and Collaborators

• Sankyo Pharma Gmbh

Investigators

• Principal Investigator: Anthony Heagerty, MD, University of Manchester, Dept. of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00311155
• Other Study ID Numbers: SP-OLM-03-05; 2005-004659-36
• First Posted: Apr 5, 2006
• Last Update Posted: Dec 10, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Olmesartan medoxomil; Hypertension
• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Study Results

Participant Flow

Recruitment Details	The trial was conducted between April 2006 and April 2008 in 9 European countries at 58 investigational sites. The countries participating were: Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Switzerland, and United Kingdom.

Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
Period Title: Overall Study
STARTED	694
COMPLETED	601
NOT COMPLETED	93

Baseline Characteristics

Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
Overall Participants	694
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.16 (12.06)
Sex: Female, Male (Count of Participants)
Female	337 48.6%
Male	357 51.4%
Region of Enrollment (participants) [Number]
Portugal	12 1.7%
France	121 17.4%
Belgium	94 13.5%
Austria	35 5%
Netherlands	43 6.2%
Germany	207 29.8%
United Kingdom	141 20.3%
Italy	35 5%
Switzerland	6 0.9%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	82.16 (16.09)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.86 (4.69)
Ethnicity (Number) [Number]
Caucasian	678 97.7%
Black	13 1.9%
Asian	3 0.4%

Outcome Measures

1. Primary Outcome

Title	The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
Description	For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.
Time Frame	Baseline to ≤20 weeks

Outcome Measure Data

Analysis Population Description

691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.

Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Measure Participants	691
Overall N=691	71.8 10.3%
OLM 20 mg N=688	12.3 1.8%
OLM 20 mg+HCTZ 12.5 mg N=580	16.4 2.4%
OLM 20 mg+HCTZ 25 mg N=446	19.2 2.8%
OLM 20 mg+HCTZ 25 mg+AML 5 mg N=296	14.9 2.1%
OLM 20 mg+HCTZ 25 mg+AML 10 mg N=176	8.5 1.2%

2. Secondary Outcome

Title	Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Description	Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients.
Time Frame	Baseline to ≤20 weeks

Outcome Measure Data

Analysis Population Description

691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.

Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Measure Participants	691
Overall N=691	84.5 12.2%
OLM 20 mg N=688	22.7 3.3%
OLM 20 mg + HCTZ 12.5 mg N=580	31.1 4.5%
OLM 20 mg + HCTZ 25 mg N=446	32.7 4.7%
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296	23.9 3.4%
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176	14.8 2.1%

3. Secondary Outcome

Title	Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
Description	Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.
Time Frame	Baseline to ≤20 weeks

Outcome Measure Data

Analysis Population Description

691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.

Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Measure Participants	691
Overall N=691	93.3 13.4%
OLM 20 mg N=688	36.6 5.3%
OLM 20 mg + HCTZ 12.5 mg N=580	52.4 7.6%
OLM 20 mg + HCTZ 25 mg N=446	48.6 7%
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296	33.4 4.8%
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176	20.4 2.9%

4. Secondary Outcome

Title	Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Description	Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough
Time Frame	Baseline to ≤20 weeks

Outcome Measure Data

Analysis Population Description

691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.

Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Measure Participants	691
Overall N=691	92.6 13.3%
OLM 20 mg N=688	34.2 4.9%
OLM 20 mg + HCTZ 12.5 mg N=580	49.6 7.1%
OLM 20 mg + HCTZ 25 mg N=446	46.6 6.7%
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296	33.3 4.8%
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176	20.5 3%

5. Secondary Outcome

Title	Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Time Frame	Baseline to ≤20 weeks

Outcome Measure Data

Analysis Population Description

691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.

Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Measure Participants	691
Overall N=691	-15.73 (7.98)
OLM 20 mg N=688	-6.44 (7.53)
OLM 20 mg + HCTZ 12.5 mg N=580	-10.15 (7.54)
OLM 20 mg + HCTZ 25 mg N=446	-13.04 (7.67)
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296	-14.03 (8.27)
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176	-14.47 (8.86)

6. Secondary Outcome

Title	Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Time Frame	Baseline to ≤20 weeks

Outcome Measure Data

Analysis Population Description

691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.

Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Measure Participants	691
Overall N=691	-29.58 (13.52)
OLM 20 mg N=688	-11.97 (11.42)
OLM 20 mg + HCTZ 12.5 mg N=580	-19.55 (12.12)
OLM 20 mg + HCTZ 25 mg N=446	-24.51 (13.14)
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296	-27.06 (13.72)
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176	-28.02 (13.52)

Adverse Events

Time Frame	The time frame was from baseline to up to 20 weeks of treatment
Adverse Event Reporting Description	Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
Arm/Group Title	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Arm/Group Description	Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
All Cause Mortality
	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
	Affected / at Risk (%)	# Events
Total	7/694 (1%)
Cardiac disorders
Acute myocardial infarction	1/694 (0.1%)
Myocardial infacrtion	1/694 (0.1%)
Gastrointestinal disorders
Inguinal hernia	1/694 (0.1%)
Infections and infestations
Cellulitis	1/694 (0.1%)
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis	1/694 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer	1/694 (0.1%)
Respiratory, thoracic and mediastinal disorders
Lung disorder	1/694 (0.1%)
Other (Not Including Serious) Adverse Events
	Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
	Affected / at Risk (%)	# Events
Total	293/694 (42.2%)
General disorders
Oedema peripheral	32/694 (4.6%)
Infections and infestations
bronchitis	46/694 (6.6%)
Urinary tract infection	26/694 (3.7%)
Nasopharyngitis	17/694 (2.4%)
Upper respiratory tract infection	17/694 (2.4%)
Musculoskeletal and connective tissue disorders
Back pain	25/694 (3.6%)
Pain in extremity	15/694 (2.2%)
Nervous system disorders
Dizziness	77/694 (11.1%)
Headache	23/694 (3.3%)
Respiratory, thoracic and mediastinal disorders
cough	15/694 (2.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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