VALENCIA: Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01368536
• Collaborator: (none)
• Enrollment: 975
• Locations: 97
• Arms: 3
• Duration (Months): 9.1
• Patients Per Site: 10.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Stage 2 Hypertension; Diabetes	Drug: Valturna; Drug: Amlodipine; Drug: Chlorthalidone; Drug: Placebo of Valturna Tablet; Drug: Placebo Capsule	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 975 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12-week, Multi-Center, Randomized Double-Blind, Active Control Parallel Group Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Valturna At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	Drug: Valturna; Valturna (aliskiren 150 mg/valsartan 160 mg) tablet; Drug: Placebo of Valturna Tablet; Matching placebo of valturna tablet; Drug: Placebo Capsule; Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule
Active Comparator: Valturna + Amlodipine At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.	Drug: Valturna; Valturna (aliskiren 150 mg/valsartan 160 mg) tablet; Drug: Amlodipine; Amlodipine 5 mg and 10 mg capsule; Drug: Placebo of Valturna Tablet; Matching placebo of valturna tablet; Drug: Placebo Capsule; Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule
Active Comparator: Valturna + chlorthalidone At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.	Drug: Valturna; Valturna (aliskiren 150 mg/valsartan 160 mg) tablet; Drug: Chlorthalidone; Chlorthalidone 15 mg and 25 mg capsule; Drug: Placebo of Valturna Tablet; Matching placebo of valturna tablet; Drug: Placebo Capsule; Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone [Baseline, 12 weeks]

   Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.

Secondary Outcome Measures

1. Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone [Baseline, 12 weeks]

   Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.

2. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment [Baseline, 12 weeks]

   Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.

3. Percentage of Responders After Treatment [Baseline, 12 weeks]

   Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg

4. Percentage of Patients Achieving Blood Pressure Control After Treatment [12 weeks]

   Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg.

5. Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone [12 weeks]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients with stage 2 hypertension within protocol limits at randomization

• Patients with type 2 diabetes mellitus with HgA1c less than or equal to 9%

• Patients with newly diagnosed hypertension or patients who have not received antihypertensive therapy for at least 4 weeks prior to screening

Exclusion Criteria:

• Patients taking 4 or more antihypertensive medications at screening visit

• Patients with uncontrolled BP (> 140/90 mmHg) while taking 3 or more antihypertensives at their maximum approved doses

• Type 2 diabetes mellitus requiring insulin treatment

• Patients with HgA1c > 9%

• Patients with known gout

• Known history of cancer within the past 5 years

• Patients who are pregnant or nursing mothers

• Patients who have participated in an investigational clinical trial within the 30 days prior to screening.

• Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Athens	Alabama	United States	35611
2	Novartis Investigative Site	Florence	Alabama	United States	35630
3	Novartis Investigative Site	Huntsville	Alabama	United States	35801
4	Novartis Investigative Site	Montgomery	Alabama	United States	36106
5	Novartis Investigative Site	Muscle Shoals	Alabama	United States	35662
6	Novartis Investigative Site	Chandler	Arizona	United States	85224
7	Novartis Investigative Site	Little Rock	Arkansas	United States	72204
8	Novartis Investigative Site	Buena Park	California	United States	90620
9	Novartis Investigative Site	Fair Oaks	California	United States	95628
10	Novartis Investigative Site	Fresno	California	United States	93726
11	Novartis Investigative Site	Healdsburg	California	United States	95448
12	Novartis Investigative Site	Los Angeles	California	United States	90057
13	Novartis Investigative Site	Orangevale	California	United States	95662
14	Novartis Investigative Site	Riverside	California	United States	92506
15	Novartis Investigative Site	Roseville	California	United States	95661
16	Novartis Investigative Site	Sacramento	California	United States	95816
17	Novartis Investigative Site	Santa Ana	California	United States	92701
18	Novartis Investigative Site	West Covina	California	United States	91790
19	Novartis Investigative Site	Shelton	Connecticut	United States	06484
20	Novartis Investigative Site	Fort Lauderdale	Florida	United States	33306
21	Novartis Investigative Site	Ft. Lauderdale	Florida	United States	33308
22	Novartis Investigative Site	Jupiter	Florida	United States	33458
23	Novartis Investigative Site	Lauderdale Lakes	Florida	United States	33319
24	Novartis Investigative Site	North Miami Beach	Florida	United States	33169
25	Novartis Investigative Site	St. Petersburg	Florida	United States	33701
26	Novartis Investigative Site	Tampa	Florida	United States	33603
27	Novartis Investigative Site	West Palm Beach	Florida	United States	33409
28	Novartis Investigative Site	Augusta	Georgia	United States	30904
29	Novartis Investigative Site	Honolulu	Hawaii	United States	96813
30	Novartis Investigative Site	Chicago	Illinois	United States	60607
31	Novartis Investigative Site	Chicago	Illinois	United States	60610
32	Novartis Investigative Site	Chicago	Illinois	United States	60617
33	Novartis Investigative Site	Gurnee	Illinois	United States	60031
34	Novartis Investigative Site	Lansing	Kansas	United States	66043
35	Novartis Investigative Site	Topeka	Kansas	United States	66606
36	Novartis Investigative Site	Beltsville	Maine	United States	20705
37	Novartis Investigative Site	Waltham	Massachusetts	United States	02453
38	Novartis Investigative Site	Wellesley Hills	Massachusetts	United States	02481-2106
39	Novartis Investigative Site	Brooklyn Center	Minnesota	United States	55430-2168
40	Novartis Investigative Site	Belzoni	Mississippi	United States	39038
41	Novartis Investigative Site	Jackson	Mississippi	United States	39209
42	Novartis Investigative Site	Picayune	Mississippi	United States	39466
43	Novartis Investigative Site	Kansas City	Missouri	United States	64111
44	Novartis Investigative Site	Ozark	Missouri	United States	65721
45	Novartis Investigative Site	St. Louis	Missouri	United States	63110-1093
46	Novartis Investigative Site	St. Louis	Missouri	United States	63128
47	Novartis Investigative Site	St. Louis	Missouri	United States	63141
48	Novartis Investigative Site	Omaha	Nebraska	United States	68134
49	Novartis Investigative Site	Henderson	Nevada	United States	89014
50	Novartis Investigative Site	Las Vegas	Nevada	United States	89119
51	Novartis Investigative Site	Toms River	New Jersey	United States	08753
52	Novartis Investigative Site	Toms River	New Jersey	United States	08755
53	Novartis Investigative Site	Trenton	New Jersey	United States	08629
54	Novartis Investigative Site	Buffalo	New York	United States	14209
55	Novartis Investigative Site	Camillus	New York	United States	13031
56	Novartis Investigative Site	Asheboro	North Carolina	United States	27204
57	Novartis Investigative Site	Asheville	North Carolina	United States	28801
58	Novartis Investigative Site	Greensboro	North Carolina	United States	27401
59	Novartis Investigative Site	Greensboro	North Carolina	United States	27408
60	Novartis Investigative Site	Shelby	North Carolina	United States	28150
61	Novartis Investigative Site	Winston-Salem	North Carolina	United States	27103
62	Novartis Investigative Site	Fargo	North Dakota	United States	58103
63	Novartis Investigative Site	Cincinnati	Ohio	United States	45219
64	Novartis Investigative Site	Cincinnati	Ohio	United States	45224
65	Novartis Investigative Site	Columbus	Ohio	United States	43201
66	Novartis Investigative Site	Lyndhurst	Ohio	United States	44124
67	Novartis Investigative Site	Zanesville	Ohio	United States	43701
68	Novartis Investigative Site	Oklahoma City	Oklahoma	United States	73132-4904
69	Novartis Investigative Site	Oklahoma City	Oklahoma	United States	73134
70	Novartis Investigative Site	Portland	Oregon	United States	97232
71	Novartis Investigative Site	Reading	Pennsylvania	United States	19609
72	Novartis Investigative Site	Uniontown	Pennsylvania	United States	15401
73	Novartis Investigative Site	Wallingford	Pennsylvania	United States	19086
74	Novartis Investigative Site	Charleston	South Carolina	United States	29407
75	Novartis Investigative Site	Charleston	South Carolina	United States	29412
76	Novartis Investigative Site	Easley	South Carolina	United States	29640
77	Novartis Investigative Site	Greenville	South Carolina	United States	29615
78	Novartis Investigative Site	Mt. Pleasant	South Carolina	United States	29464
79	Novartis Investigative Site	Summerville	South Carolina	United States	29485
80	Novartis Investigative Site	Varnville	South Carolina	United States	29944
81	Novartis Investigative Site	Fayetteville	Tennessee	United States	33734
82	Novartis Investigative Site	Arlington	Texas	United States	76012
83	Novartis Investigative Site	Austin	Texas	United States	78728-6904
84	Novartis Investigative Site	Austin	Texas	United States	78735
85	Novartis Investigative Site	Dallas	Texas	United States	75235
86	Novartis Investigative Site	Houston	Texas	United States	77025
87	Novartis Investigative Site	Houston	Texas	United States	77074
88	Novartis Investigative Site	Houston	Texas	United States	77081
89	Novartis Investigative Site	Houston	Texas	United States	77083
90	Novartis Investigative Site	Lake Jackson	Texas	United States	77566
91	Novartis Investigative Site	Pasadena	Texas	United States	77504
92	Novartis Investigative Site	Plano	Texas	United States	75093
93	Novartis Investigative Site	Richardson	Texas	United States	75080
94	Novartis Investigative Site	St. George	Utah	United States	84790
95	Novartis Investigative Site	Arlington	Virginia	United States	22203
96	Novartis Investigative Site	Carolina		Puerto Rico	00983
97	Novartis Investigative Site	San Juan		Puerto Rico	00926

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01368536
• Other Study ID Numbers: CSPV100AUS05
• First Posted: Jun 8, 2011
• Last Update Posted: Mar 21, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Novartis Pharmaceuticals: High blood pressure; diabetes
• Additional relevant MeSH terms: Hypertension; Diabetes Mellitus; Amlodipine; Chlorthalidone

Study Results

Participant Flow

Pre-assignment Detail	Of the 975 patients screened, 417 were randomized.

Arm/Group Title	Valturna	Valturna + Amlodipine	Valturna + Chlorthalidone
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
Period Title: Overall Study
STARTED	138	137	142
Full Analysis Set	138	137	141
COMPLETED	87	78	83
NOT COMPLETED	51	59	59

Baseline Characteristics

Arm/Group Title	Valturna	Valturna + Amlodipine	Valturna + Chlorthalidone	Total
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.	Total of all reporting groups
Overall Participants	138	137	141	416
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.7 (8.65)	56.0 (9.56)	54.6 (9.35)	55.1 (9.20)
Sex: Female, Male (Count of Participants)
Female	73 52.9%	73 53.3%	70 49.6%	216 51.9%
Male	65 47.1%	64 46.7%	71 50.4%	200 48.1%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone
Description	Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated and consequentially was underpowered for adequate statistical analysis

Arm/Group Title	Valturna	Valturna + Amlodipine
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
Measure Participants	0	0

2. Secondary Outcome

Title	Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone
Description	Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated and consequentially was underpowered for adequate statistical analysis

Arm/Group Title	Valturna	Valturna + Chlorthalidone
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
Measure Participants	0	0

3. Secondary Outcome

Title	Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment
Description	Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated and consequentially was underpowered for adequate statistical analysis

Arm/Group Title	Valturna	Valturna + Amlodipine	Valturna + Chlorthalidone
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
Measure Participants	0	0	0

4. Secondary Outcome

Title	Percentage of Responders After Treatment
Description	Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated and consequentially was underpowered for adequate statistical analysis

Arm/Group Title	Valturna	Valturna + Amlodipine	Valturna + Chlorthalidone
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
Measure Participants	0	0	0

5. Secondary Outcome

Title	Percentage of Patients Achieving Blood Pressure Control After Treatment
Description	Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated and consequentially was underpowered for adequate statistical analysis

Arm/Group Title	Valturna	Valturna + Amlodipine	Valturna + Chlorthalidone
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
Measure Participants	0	0	0

6. Secondary Outcome

Title	Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety Set - Consists of all patients who received at least one dose of the double-blind study drug. Patients were analyzed according to the treatment that they received.

Arm/Group Title	Valturna	Valturna + Amlodipine	Valturna + Chlorthalidone
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
Measure Participants	138	137	142
Adverse Events	62 44.9%	54 39.4%	58 41.1%
Serious Adverse Events	0 0%	0 0%	0 0%
Death	0 0%	0 0%	0 0%

Adverse Events

Arm/Group Title	Valturna		Valturna + Amlodipine		Valturna + Chlorthalidone
Arm/Group Description	At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.		At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.		At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
All Cause Mortality
	Valturna		Valturna + Amlodipine		Valturna + Chlorthalidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Valturna		Valturna + Amlodipine		Valturna + Chlorthalidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		0/137 (0%)		0/142 (0%)
Other (Not Including Serious) Adverse Events
	Valturna		Valturna + Amlodipine		Valturna + Chlorthalidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/138 (16.7%)		16/137 (11.7%)		23/142 (16.2%)
Gastrointestinal disorders
Diarrhoea	8/138 (5.8%)		4/137 (2.9%)		2/142 (1.4%)
Nervous system disorders
Dizziness	3/138 (2.2%)		4/137 (2.9%)		11/142 (7.7%)
Headache	16/138 (11.6%)		9/137 (6.6%)		10/142 (7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.