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Based on results from an ALTITUDE study interim analysis, testing aliskiren concomitantly with an ACE inhibitor or ARB, in diabetics with renal impairment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valturna | Experimental | 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. |
|
| Valturna + Amlodipine | Active Comparator | 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. |
|
| Valturna + chlorthalidone | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valturna | Drug | Valturna (aliskiren 150 mg/valsartan 160 mg) tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Athens | Alabama | 35611 | United States | ||
| Novartis Investigative Site |
Of the 975 patients screened, 417 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Amlodipine | Drug | Amlodipine 5 mg and 10 mg capsule |
|
| Chlorthalidone | Drug | Chlorthalidone 15 mg and 25 mg capsule |
|
| Placebo of Valturna Tablet | Drug | Matching placebo of valturna tablet |
|
| Placebo Capsule | Drug | Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule |
|
| Baseline, 12 weeks |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment | 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. | Baseline, 12 weeks |
| Percentage of Responders After Treatment | Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg | Baseline, 12 weeks |
| Percentage of Patients Achieving Blood Pressure Control After Treatment | Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg. | 12 weeks |
| 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 |
| Florence |
| Alabama |
| 35630 |
| United States |
| Novartis Investigative Site | Huntsville | Alabama | 35801 | United States |
| Novartis Investigative Site | Montgomery | Alabama | 36106 | United States |
| Novartis Investigative Site | Muscle Shoals | Alabama | 35662 | United States |
| Novartis Investigative Site | Chandler | Arizona | 85224 | United States |
| Novartis Investigative Site | Little Rock | Arkansas | 72204 | United States |
| Novartis Investigative Site | Buena Park | California | 90620 | United States |
| Novartis Investigative Site | Fair Oaks | California | 95628 | United States |
| Novartis Investigative Site | Fresno | California | 93726 | United States |
| Novartis Investigative Site | Healdsburg | California | 95448 | United States |
| Novartis Investigative Site | Los Angeles | California | 90057 | United States |
| Novartis Investigative Site | Orangevale | California | 95662 | United States |
| Novartis Investigative Site | Riverside | California | 92506 | United States |
| Novartis Investigative Site | Roseville | California | 95661 | United States |
| Novartis Investigative Site | Sacramento | California | 95816 | United States |
| Novartis Investigative Site | Santa Ana | California | 92701 | United States |
| Novartis Investigative Site | West Covina | California | 91790 | United States |
| Novartis Investigative Site | Shelton | Connecticut | 06484 | United States |
| Novartis Investigative Site | Fort Lauderdale | Florida | 33306 | United States |
| Novartis Investigative Site | Fort Lauderdale | Florida | 33308 | United States |
| Novartis Investigative Site | Jupiter | Florida | 33458 | United States |
| Novartis Investigative Site | Lauderdale Lakes | Florida | 33319 | United States |
| Novartis Investigative Site | North Miami Beach | Florida | 33169 | United States |
| Novartis Investigative Site | St. Petersburg | Florida | 33701 | United States |
| Novartis Investigative Site | Tampa | Florida | 33603 | United States |
| Novartis Investigative Site | West Palm Beach | Florida | 33409 | United States |
| Novartis Investigative Site | Augusta | Georgia | 30904 | United States |
| Novartis Investigative Site | Honolulu | Hawaii | 96813 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60607 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60610 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60617 | United States |
| Novartis Investigative Site | Gurnee | Illinois | 60031 | United States |
| Novartis Investigative Site | Lansing | Kansas | 66043 | United States |
| Novartis Investigative Site | Topeka | Kansas | 66606 | United States |
| Novartis Investigative Site | Beltsville | Maine | 20705 | United States |
| Novartis Investigative Site | Waltham | Massachusetts | 02453 | United States |
| Novartis Investigative Site | Wellesley Hills | Massachusetts | 02481-2106 | United States |
| Novartis Investigative Site | Brooklyn Center | Minnesota | 55430-2168 | United States |
| Novartis Investigative Site | Belzoni | Mississippi | 39038 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | United States |
| Novartis Investigative Site | Picayune | Mississippi | 39466 | United States |
| Novartis Investigative Site | Kansas City | Missouri | 64111 | United States |
| Novartis Investigative Site | Ozark | Missouri | 65721 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63110-1093 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63128 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68134 | United States |
| Novartis Investigative Site | Henderson | Nevada | 89014 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89119 | United States |
| Novartis Investigative Site | Toms River | New Jersey | 08753 | United States |
| Novartis Investigative Site | Toms River | New Jersey | 08755 | United States |
| Novartis Investigative Site | Trenton | New Jersey | 08629 | United States |
| Novartis Investigative Site | Buffalo | New York | 14209 | United States |
| Novartis Investigative Site | Camillus | New York | 13031 | United States |
| Novartis Investigative Site | Asheboro | North Carolina | 27204 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27401 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27408 | United States |
| Novartis Investigative Site | Shelby | North Carolina | 28150 | United States |
| Novartis Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Novartis Investigative Site | Fargo | North Dakota | 58103 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45224 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43201 | United States |
| Novartis Investigative Site | Lyndhurst | Ohio | 44124 | United States |
| Novartis Investigative Site | Zanesville | Ohio | 43701 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73132-4904 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73134 | United States |
| Novartis Investigative Site | Portland | Oregon | 97232 | United States |
| Novartis Investigative Site | Reading | Pennsylvania | 19609 | United States |
| Novartis Investigative Site | Uniontown | Pennsylvania | 15401 | United States |
| Novartis Investigative Site | Wallingford | Pennsylvania | 19086 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29407 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29412 | United States |
| Novartis Investigative Site | Easley | South Carolina | 29640 | United States |
| Novartis Investigative Site | Greenville | South Carolina | 29615 | United States |
| Novartis Investigative Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Novartis Investigative Site | Summerville | South Carolina | 29485 | United States |
| Novartis Investigative Site | Varnville | South Carolina | 29944 | United States |
| Novartis Investigative Site | Fayetteville | Tennessee | 33734 | United States |
| Novartis Investigative Site | Arlington | Texas | 76012 | United States |
| Novartis Investigative Site | Austin | Texas | 78728-6904 | United States |
| Novartis Investigative Site | Austin | Texas | 78735 | United States |
| Novartis Investigative Site | Dallas | Texas | 75235 | United States |
| Novartis Investigative Site | Houston | Texas | 77025 | United States |
| Novartis Investigative Site | Houston | Texas | 77074 | United States |
| Novartis Investigative Site | Houston | Texas | 77081 | United States |
| Novartis Investigative Site | Houston | Texas | 77083 | United States |
| Novartis Investigative Site | Lake Jackson | Texas | 77566 | United States |
| Novartis Investigative Site | Pasadena | Texas | 77504 | United States |
| Novartis Investigative Site | Plano | Texas | 75093 | United States |
| Novartis Investigative Site | Richardson | Texas | 75080 | United States |
| Novartis Investigative Site | St. George | Utah | 84790 | United States |
| Novartis Investigative Site | Arlington | Virginia | 22203 | United States |
| Novartis Investigative Site | Carolina | 00983 | Puerto Rico |
| Novartis Investigative Site | San Juan | 00926 | Puerto Rico |
| FG001 | 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. |
| FG002 | 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. |
| Full Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | Baseline, 12 weeks |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone | 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. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | Baseline, 12 weeks |
| |||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment | 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. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | Baseline, 12 weeks |
| |||||||||||||||||||||||
| Secondary | Percentage of Responders After Treatment | Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | Baseline, 12 weeks |
| |||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Blood Pressure Control After Treatment | Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 12 weeks |
| |||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Number | Participants | 12 weeks |
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 138 | 23 | 138 | ||
| EG001 | 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. | 0 | 137 | 16 | 137 | ||
| EG002 | 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. | 0 | 142 | 23 | 142 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D002752 | Chlorthalidone |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
|
| OG002 | 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. |
|
|
|
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. |
|
|